Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

The subjects in this arm will receive Cyclophosphamide 300mg/m2/d and Fludarabine 30mg/m2/d from day-4 to day-2. Subjects will be treated with six administrations of anti-MESO CAR-T cells three times weekly (Monday-Wednesday-Friday) for two weeks. In the first week, total 1×109 or 3×109 will be infused, the second week is to plan three times consecutive infusions of 1x109 or 3×109 anti-MESO CAR-T cells each time.

Subjects will be enrolled serially. For subject safety, the preceding subject must have completed therapy and be 28 days from their last infusion before the next subject can be treated.

Interventions:

* Drug: anti-MESO CAR-T cells
* Drug: Fludarabine
* Drug: Cyclophosphamide

Autologous genetically modified anti-MESO CAR T cells

anti-MESO CAR T cells

Jun Zhang, MD, PhD

Yan Shi, MD, PhD

Jun Zhang, MD & Ph. D

The goal of this clinical trial is to study the safety, efficacy, and pharmacokinetics of mRNA-engineered anti-Mesothelin (MESO) Chimeric Antigen Receptor T-Cell (CAR-T cells) therapy in patients with mesothelin expression-positive, advanced solid tumors that have failed at least first-line or second-line therapy.

This phase I study is being conducted to establish safety, pharmacokinetics, and preliminary efficacy of intravenous (IV) mRNA electroporated fully-humanized anti-MESO re-directed autologous T cell administration in patients with chemotherapy-refractory metastatic solid tumors.

The study will adopt the "3+3" dose escalation design exploring two doses of 1×109 and 3×109. The administration is planned to infuse 3 times a week for 2 consecutive weeks.

• The subjects will receive a total dose of 1x109 RNA transduced anti-MESO CAR-T cells in the first week, following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given over 3 days by intravenous infusion. If there is no obvious dose-limiting toxicity (DLT) after the first week of infusion, three times consecutive infusions of 1x109 anti-MESO CAR-T cells each time is planned in the second week. Each subject needs to be observed for at least 2 weeks (14 days) after completing the last infusion. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of anti-MESO CAR-T cells.

Anti-mesothelin CAR-T Cells With Advanced Refractory Solid Tumors

An Open, Single-center, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of mRNA CAR-mesothelin T Cells in Patients With Advanced Refractory Solid Tumors

Immunohistochemical method to detect the expression of mesothelin, CT or magnetic resonance image（MRI） evaluation efficacy, statistical method (SPSS 24.0) to assess the correlation between mesothelin expression level and efficacy

Incidence of Treatment Emergent Adverse Event

Incidence of Treatment Related Adverse Events

Incidence of AEs of Special Interest and Serious Adverse Events

Incidence of Treatment Emergent Adverse Event, Treatment Related adverse events, AEs of special interest and serious adverse events

Objective response rate based on investigator's evaluation

ORR based on independent review committee evaluation

Disease control rate based on the investigator's evaluation

Duration of Remission based on the investigator's evaluation

Time to remission based on the investigator's evaluation

Progression-free survival (PFS) based on the investigator's evaluation

According to the EUROPEAN Organization for Research and Treatment of Cancer, Eortc, Quality of Life QuestionNare-Core 3, QOQ-C30), ERTC QLQ-C30, evaluated subject's quality of life.

the highest concentration (Cmax) of anti-human MESO T cells in the peripheral blood after CAR T cell infusion

the area under the curve of 28 days of anti-human MESO T cells in the peripheral blood after CAR T cell infusion

Positive rate of Human Anti-CAR Antibodies after CAR T cell infusion

UTC Therapeutics Inc.

Ruijin Hospital

Chief of Department of Oncology

Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Herpes Simplex

Recurrence

Uterine Cervical Neoplasms

Virus Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antibodies

Immunoglobulins

Muromonab-CD3

Three subjects will be enrolled in this cohort. First subject will receive first injection in dose level of 1 million CCID50/mL. If tolerated, second injection for this subject will be accelerated to 10 millions CCID50/mL. If tolerated, the third injection will be further accelerated to 100 million CCID50/mL. The maximum volume for per injection time point is 8 mL. Injection will repeat every two weeks until disease progression or unacceptable toxicity or withdrawn of consent or no lesion suitable for injection or death. If dose limiting toxicity (DLT) happens in any dose level, the injection dose will be decrease to the last tolerable level.

Fifteen subjects will be enrolled in this cohort. The maximal tolerable dose (MTD) confirmed in the first stage will be utilized in 15 patients. This stage should not be initiated before the completion of dose escalation of all three subjects in the first stage. Treatment will be repeated every two weeks until disease progression or unacceptable toxicity or withdrawn of consent or no lesion suitable for injection or death. Dose interruption, not reduction, is permitted. Treatment will be terminated if toxicity-related treatment interrupt is longer than 28 days. Radiology assessment will be conducted every six weeks.

BS-006 is an engineered recombinant type II herpes simplex virus (HSV2) designed and produced by Wuhan Binhui Biopharmaceutical Co., Ltd. It was derived from HSV2 strain HG52. ICP34.5 and ICP47 genes were deleted to ensure abortive infection and immune destruction in normal cells. Bispecific T cell engager of anti-CD3 antibody and anti-PD-L1 antibody were constructed and inserted into HG52 strain genome.

BS-006

Shaoxing Sun, M. D.

Shaoxing Sun

Hui Qiu, Ph.D.

Shaoxing Sun, M.D.

Sufang Tian, Ph.D

Chunxu Yang, Ph.D.

Qingming Xiang, Ph.D.

Zijie Mei, Ph.D.

Min Chen, M.M.

Hui Qiu, Ph. D.

This is a two-stage phase I clinical trial with oncolytic viruses BS-006 in recurrent or metastasis cervical cancer patients who failed in second line treatment.

This trial includes accelerated dose-escalation stage and dose-expansion stage. An engineered modification oncolytic viruses, BS-006, derived from type II herpes simplex virus strain are planed to be injected into the tumor every two weeks until disease progression or unacceptable toxicity or withdrawn of consent or no lesion suitable for injection or death. In dose-escalation stage, there are three dose levels (1 million, 10 millions, 100 millions 50 % cell culture infectious dose (CCID50)/ml) . Treatment dose will escalate to next higher level if no dose limiting toxicity happens for one time of injection in 3 subjects. Maximal tolerable dose is defined as the highest dose with no more than one dose limiting toxicity and is recommended for dose expansion stage. In dose-expansion stage, 15 subjects will be enrolled. BS-006 viruses will be injected into proper tumor lesions every 2 weeks until disease progression or unacceptable toxicity or withdrawn of consent or no lesion suitable for injection or death. Radiology assessment will repeat every 6 weeks. Dose interruption, not reduction, is permitted in this stage.

First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer

A First-in-human Phase I Two-stage Clinical Trial for Intratumoral Injection of Recombinant Oncolytic Type II Herpes Simplex Virus (BS-006) in Patients With Recurrent Cervical Cancer

The dose level at which there is no more than one DLT happens in dose-escalation stage

The incidence of adverse events and severity graded according to CTCAE 5.0

Detection of BS-006 virus copy numbers in urine, stool, saliva, blood and wiper of injection point and perineum

Tumor change assessed by investigator according to RECIST 1.1

Rate of subjects who showed tumor shrinkage for any untreated lesion

Proportion of participants without tumor recurrence or death

Binhui Biopharmaceutical Co., Ltd.

Zhongnan Hospital

Chief Physician and Director of Department of Radiation and Clinical Oncology (Gynaecological Oncology

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

One course will last 28 days. Oral administration at a dose of 80 mg/day, 120mg/day or 160 mg/day for 21 consecutive days, with a 1-week washout period.

Regorafenib

One course will last 28 days. Given once every 2 weeks at a dose of 3.0 mg/kg.

Kohei Shitara, Dr

the efficacy and safety ofhe use of regorafenib in combination with nivolumab

The present trial consists of a dose-escalation cohort to verify the tolerability of nivolumab and regorafenib when used in combination for patients with solid tumors, and to examine the clinical recommended dose(RD). The trial also consists of an expansion cohort to examine the safety and efficacy when the clinical RD is administered for several advanced solid tumors.

In the dose-escalation cohort, three patients with solid tumors will be administered 3.0 mg/kg of nivolumab once every 2 weeks and regorafenib daily for 21days, with a 1-week washout period at dose of 80 mg (level 1), 120 mg (level 2), or 160 mg (level 3). As a general rule, one cycle will last 28 days (day 1-29); however, in the event of treatment prolongation, the cycle period will be extended. The Dose Limiting Toxicity(DLT) evaluation period will be 28 days. Furthermore, for each level, three additional subjects will be added depending on the state of DLT.

In the expansion cohort, the target subject sample will consist of approximately 30 patients who will be administered 3.0 mg/kg of nivolumab once every 2 weeks, and the clinical RD of regorafenib will be determined in the dose-escalation cohort.

Regorafenib and Nivolumab Simultaneous Combination Therapy

Regorafenib and Nivolumab Simultaneous Combination Therapy for Advanced and Metastatic Solid Tumors: Phase I Clinical Trial

Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

Ono Pharmaceutical Co. Ltd

Bayer Yakuhin, Ltd.

Kohei Shitara

Assistant Chief of Gastrointestinal Oncology Division

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Interleukin-12

IL-12 gene

Brian J. Miles, M.D.

This study is designed to determine the safety of IL-12 gene therapy for patients with recurrence of prostate cancer after radiation therapy and those with or without metastatic disease with a prostate gland intact. These, of course, would include recurrent prostate cancer after definitive radiation therapy. The prostate cancer will be treated with a prostatic injection of a replication-defective adenovirus vector delivering the IL-12 gene. Following virus injection, patients will be hospitalized for 23 hours for observation. Only one course of therapy will be administered. Each patient will be carefully monitored for toxic effects. Three to five patients will be tested with a low dose of virus and if there are no serious adverse side effects, the dose will be slowly escalated in subsequent groups of 3-5 patients or until unacceptable toxicity is reached. Effectiveness will be monitored by serum prostate-specific antigen (PSA), transrectal ultrasound of the prostate, prostate biopsy and comparison of survival times to historical survival times for patients with radiation recurrent prostate tumors. The primary objective of this initial study is to determine whether the treatment is associated with significant toxicity.

The development of a clinical trial for gene therapy in prostate cancer will be coordinated with our collaborators at Baylor involved in similar studies in order to facilitate the approval process. We have submitted a proposal to the NIH Recombinant DNA Advisory Committee (RAC) committee for accelerated review. A detailed clinical protocol and informed consent for a Phase I clinical trial of gene therapy for prostate cancer has been approved by the Baylor Affiliates Review Board and the FDA.

Human subjects included in this project will be limited to men who have biopsy-proven local recurrence or persistence of cancer in the prostate gland with or without metastatic disease after hormone therapy, cryosurgery and/or definitive irradiation therapy. Patients with biopsy-proven prostate cancer, clinical stages T1-T3, Nx-N1 or M0-M1 are eligible. Biologically active local recurrence of tumor will be defined as biopsy-proven cancer in the prostate, at least one year after the completion of radiation therapy, in a patient who has a rising serum PSA level on at least 3 separate occasions at least 2 weeks apart.

Patients will also be carefully followed to document toxicity, using standard CTEP toxicity criteria. Responses will be categorized as follows: progressive disease, stable disease, partial objective response, and complete objective response. Progressive disease will be defined as a rise in the serum PSA level by 25% in the first 3 months and thereafter, a positive biopsy in conjunction with an enlarging nodule on digital rectal exam or an enlarging hypoechoic lesion on ultrasound, or the development of new symptoms clearly related to the cancer in the presence of a positive biopsy, or the presence on biopsy of cancer of higher grade or cancer that is more extensive. A complete response will be defined as a serum PSA level that decreases to less than 1 ng/ml, in combination with a negative biopsy of the prostate and the absence of symptoms referable to cancer. A partial objective response would be a PSA level that decreases by at least 50% compared to baseline in association with a biopsy result that shows clearly diminished or minimum but persistent cancer cells.

This Phase I study is designed to evaluate the safety of Adv/IL-12 gene therapy with an intent to offer a potential therapeutic advantage. The potential risks associated with the use of gene therapy in this group would appear reasonable in so far as evaluations will be frequent and progression (should it occur) will be found early and allow rapid movement of the patient to other possible therapies. Effectiveness will be monitored by serum PSA, transrectal ultrasound of the prostate, prostate biopsy and comparison of survival times to historical survival times for patients with radiation recurrent prostate tumors. Additional research laboratory analyses will be performed to evaluate the immune response engendered by this gene therapy protocol. This will consist of analysis of serum and/or plasma and urine for systemic cytokine production using standard ELISA methodologies that we have performed in previous studies. In addition we will collect whole blood for the analysis of T cells by flow cytometry. We have established protocols for this analysis that can detect total CD4 and CD8 cells as well as those that express markers of activation such as HLA/DR.

Vector Delivery of the IL-12 Gene in Men With Prostate Cancer

Phase I Study of Adenoviral Vector Delivery of The IL-12 Gene in Men With Recurrence or Persistent Cancer of the Prostate After Primary Therapy With or Without Metastatic Disease (SPORE)

Baylor College of Medicine

Baily

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antibodies, Bispecific

IMP-288 labeled with In111 and Lu177

O C Boerman, PhD

R Schoffelen, MD

W JG Oyen, MD PhD

W TA van der Graaf, MD PhD

This study will investigate the toxicity, safety and pharmacokinetics of pretargeted radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the preliminary efficacy of the therapy.

Pretherapy cycle with IMP-288 labeled In111.

Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer

Phase I Clinical Study of the Feasibility of Pretargeted Radioimmunotherapy of an Anti-CEA Bispecific Antibody and Lu-177-labeled Peptide in Patients With Advanced Colorectal Cancer

Radboud University Medical Center

Adenocarcinoma

Cohort Level #1 1.0 x 1010vp Cohort Level #2 5.0x1010vp Cohort Level #3 1.0 x 1011vp Cohort Level #4 5.0x1011vp Cohort Level #5 1.0 x 1012vp Cohort Level #6 5.0x1012vp

One dose only followed by a radical prostatectomy 4 weeks later.

RTVP-1 Gene

Dov Kadmon, M.D.

The purpose of this study is to conduct a Phase I clinical trial involving in situ RTVP-1 gene therapy for prostate cancer. We will conduct necessary safety evaluations on a new adenovirus that contains the human genes for RTVP-1. This virus will then be evaluated for safety in men with prostate cancer prior to radical prostatectomy. Based on the preclinical data, we hope that this treatment will induce not only a local cytotoxic and antiangiogenic effect but also, a systemic antitumor immune response capable of eradicating micrometastatic disease (the reason for recurrence in many of these patients).

The population selected for this study includes patients with locally advanced and/or poorly differentiated tumors. These patients have an unacceptably high failure rate when treated by radical prostatectomy alone (over 50% fail within 5 years). The pattern of failure varies. While some patients present with a local recurrence, many have both a local recurrence and distant metastases, or just distant metastases. It is reasonable to assume that many, if not most of these patients, actually harbor micrometastases, present but undiagnosed clinically, at the time of their radical prostatectomy. Our hypothesis is that the cytotoxic, proapoptotic, antiangiogenic and immune stimulatory activities of in-situ RTVP-1 gene therapy will lower the incidence of local tumor recurrences when given to patients prior to surgery. The second part of our hypothesis is that RTVP-1 gene therapy will induce a systemic anti-tumor immune response, which will eliminate pre-existing micrometastases in some of these patients and lower the overall failure rate.

While this Phase I study is not designed to answer these questions, we hope to obtain mechanistic evidence in support of this hypothesis. A Phase II study will then be proposed (and properly powered), to study the efficacy of this approach.

Based on our experience with HSV-tk and GCV in-situ gene therapy, it appears that maximal immune stimulation occurs about 2 weeks following vector injection. Furthermore, repeat injections of an adenoviral vector do not result in excess toxicity or in the generation of anti-adenoviral antibodies sufficient to suppress vector activity. We propose here an intraprostatic injection of RTVP-1 in an adenoviral vector 4-6 weeks prior to radical prostatectomy, in order to allow full expression of the gene therapy tissue effects.

Phase I - Pre-Radical Prostatectomy RTVP-1 Gene Therapy for Prostate Cancer

A Phase I Study of In-Situ, Neoadjuvant, Pre-Radical Prostatectomy RTVP-1 Gene Therapy in Patients With Locally Advanced Adenocarcinoma of the Prostate (SPORE)

Professor of Urology

Blood and Lymph Conditions

Immune System Diseases

Eye Diseases

Rare Diseases

Lymphoma

Intraocular Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Eye Neoplasms

Lymphosarcoma

Primary Central Nervous System Lymphoma

Micronutrients

Dermatologic Agents

Reproductive Control Agents

Leucovorin

Methotrexate

Rituximab

Immunologic Factors

Intraventricular injection of rituximab into an Ommaya reservoir on day 1 of each week. Intraventricular rituximab plus methotrexate (MTX) on day 4 of each week.

First three patients at dose A : 25 mg rituximab on day 1, and MTX (12 mg) plus rituximab (10 mg) on day 4 each week.

If there are no dose limiting toxicities at Dose A in all of the first 3 patients or in 5 of the first 6 patients, the next 3 patients will receive dose level B: 25 mg rituximab on day 1, and combination MTX (12 mg) plus rituximab (25 mg) on day 4 of each week.

Oral leucovorin rescue 24 hours after each MTX administration. Maximum injections will be 16 over 9-weeks. Subjects who experience a partial response at week 10 will be given the option for extended dosing.

Intraventricular Rituximab Plus MTX

James L. Rubenstein, MD PhD

Rituximab is the first monoclonal antibody to receive approval in the treatment of cancer and has been proven to lead to extended survival when administered intravenously in the treatment of patients with systemic non-Hodgkin's lymphoma. We have previously demonstrated that a small fraction of Rituximab administered intravenously is able to cross the blood-brain-barrier into the brain.

We will test the idea that the direct injection into the cerebrospinal fluid of Rituximab, a monoclonal antibody which attacks and kills lymphoma cells, is safe and when used in combination with methotrexate in patients with recurrent brain and intraocular lymphoma.

We will also test the idea that the combination of rituximab plus methotrexate has activity and is effective in the treatment of recurrent brain and intraocular lymphoma.

Rituximab is the first monoclonal antibody to receive FDA approval in the treatment of cancer. Intravenous administration of rituximab has been demonstrated to lead to prolongation of survival when used in combination with chemotherapy in the treatment of patients with systemic non-Hodgkin's lymphoma. We have previously demonstrated that a small fraction of Rituximab administered intravenously is able to cross the blood-brain-barrier into the brain and we have also previously demonstrated that direct intraventricular administration of Rituximab is able to achieve high concentrations within the cerebrospinal fluid ventricles and lumbar sac.

We will test the hypothesis that the direct intraventricular injection of Rituximab in combination with Methotrexate is safe and when used in combination in patients with recurrent brain and intraocular lymphoma. We will evaluate the safety of this combination by testing different dose levels of Rituximab. We will also measure the concentration of Rituximab in the intraocular compartments and cerebrospinal fluid at different time points after intraventricular administration to determine the pharmacokinetics of intrathecal Rituximab as well as the potential impact of Methotrexate on Rituximab distribution.

We will also test the hypothesis that the intraventricular administration of the combination of rituximab plus methotrexate has activity and is effective in the treatment of recurrent brain and intraocular lymphoma.

A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma

Phase I Study of Intraventricular Administration of Rituximab in Combination With Methotrexate in the Treatment of Recurrent CNS and Intraocular Lymphoma

University of California, San Francisco

Physical activity and fitness will be assessed objectively with a smartphone

Objective measurement of physical activity and fitness

Henk MW Verheul, MD, PhD

Rationale:

Optimal selection of patients with cancer eligible for a clinical trial, is of utmost importance, but can be very difficult. Patients must be sufficiently fit and have a reasonable life expectancy, to be eligible for participation in clinical trials. In current clinical practice, the ECOG/WHO performance status, is used to select patients for clinical trials, and it has proven to be an independent predictor of survival in patients with cancer. This score is based on a subjective assessment of the treating physician, which can, together with the strong motivation of some patients to participate, lead to overestimation of a patient's actual physical condition and may thereby contribute to early trial discontinuation. Participation of these patients may not only harm them, but will also hamper trial conduct and outcomes.

Both, physical activity and fitness are positively associated with survival in patients with cancer. This gives rise to the investigators hypothesis that objective measurements can be of added value in the selection process. Additionally, preliminary results in 50 patients with cancer that participated in part 1 of the "Counting Steps!" project revealed that the smartphone can produce valid and reliable assessments of physical activity and fitness, and the user friendliness was rated "good" by patients.

The investigators hypothesize that measurements of physical activity and fitness with smartphones will provide more objective and accurate information about the actual physical condition of a patient with cancer.

With a better prediction of trial feasibility (without early trial discontinuation) and overall survival in patients participating in phase I-II clinical trials, the selection of eligible trial participants could be improved. In this way, it is possible to more adequately identify patients who are most likely to successfully participate in a clinical trial and thereby have the highest chance to benefit from trial participation. Successful trial participation will provide optimal palliative care to patients and improve their quality of life. In addition, it may prohibit participation of patients who are currently incorrectly included in clinical trials and suffer from toxic therapies without having a chance to benefit from treatment. A better selection of patients will be beneficial for the trial outcomes and subsequently for the development of new anticancer drugs or treatment regimens.

Objective:

The investigators aim to:

1. Identify whether objective smartphone measurements of physical activity and fitness is predictive for trial feasibility (without early trial discontinuation) in patients with cancer participating in phase I-II clinical trials.
2. Evaluate the feasibility and acceptability of the use of the smartphone's objective assessments of physical activity and fitness in clinical practice.

Study design: Observational study

Study population:

• 135 patients with hematologic or solid cancer referred to the VU medical center for participation in phase I-II clinical trials.

Intervention:

In this observational study, patients will not receive an additional intervention.

Main study parameters/endpoints:

Prior to the start of medical treatment, physicians will rate the performance status, and participants will wear a smartphone for one week to measure the daily number of steps, to complete the 6 minute walk test using the smartphone application, and to fill out the 5-item physical function subscale of the EORTC QLQ-C30. These assessments will be repeated after 4 and 8 weeks.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

No extra visits to the hospital will be necessary. Participation in this study will not cause any additional risks or expected benefits for participants. It will only deliver knowledge, which may be used in the future to better select patients eligible for participation in phase I-II clinical trials or even for regular treatment. Participation in the study will only cost time for patients. The patients will be asked to wear a smartphone for a week, have to perform a six-minute walk test (6MWT) once in this week and have to complete a questionnaire about their own physical function once. Subsequently, patients will repeat those measurements 4 and 8 weeks after inclusion in the phase I-II clinical trial.

Counting Steps! Integration of Objectively Assessed Physical Activity and Fitness With Smartphones in Clinical Oncology Practice.

Early trial discontinuation is defined as discontinuation of trial in the first two months after inclusion, dichotomized into yes or no

Overall survival is defined as the time between start of trial participation and death of any cause and will be tracked via the registration of the original clinical trial

Progression free survival is defined as the time between trial participation and the clinically or radiologically confirmation of progressive disease (established via RECIST-criteria) as defined by the original clinical trial and will be tracked via the registration of the original clinical trial

Amsterdam UMC, location VUmc

Carcinoma

Cholangiocarcinoma

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Bile Duct Cancer

Biliary Tract Cancer

Intrahepatic Cholangiocarcinoma

Crouzon Syndrome

Jackson-Weiss Syndrome

Pfeiffer Syndrome

Hematinics

Amino Acids

Liver Extracts

Mitogens

Tyrosine Kinase Inhibitors

Tyrosine

Patients who received derazantinib orally at dose levels from 25 mg every other day (QOD) - 200 mg daily (QD) on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anti-mesothelin CAR-T Cells With Advanced Refractory Solid Tumors	NCT04981691	Refractory Mali...	anti-MESO CAR T...	18 Years - 80 Years	Ruijin Hospital
First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer	NCT05393440	Uterine Cervica...	BS-006	18 Years - 75 Years	Zhongnan Hospital
Regorafenib and Nivolumab Simultaneous Combination Therapy	NCT03406871	Advanced and Me...	Regorafenib Nivolumab	20 Years -	National Cancer Center Hospital East
Vector Delivery of the IL-12 Gene in Men With Prostate Cancer	NCT00406939	Prostatic Neopl... Prostate Cancer	IL-12 gene	18 Years -	Baylor College of Medicine
First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer	NCT05393440	Uterine Cervica...	BS-006	18 Years - 75 Years	Zhongnan Hospital
Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer	NCT00860860	Colorectal Neop...	TF2 IMP-288 labeled...	18 Years -	Radboud University Medical Center
Phase I - Pre-Radical Prostatectomy RTVP-1 Gene Therapy for Prostate Cancer	NCT00403221	Prostatic Neopl...	RTVP-1 Gene	18 Years -	Baylor College of Medicine
First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer	NCT05393440	Uterine Cervica...	BS-006	18 Years - 75 Years	Zhongnan Hospital
Vector Delivery of the IL-12 Gene in Men With Prostate Cancer	NCT00406939	Prostatic Neopl... Prostate Cancer	IL-12 gene	18 Years -	Baylor College of Medicine
A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma	NCT00221325	Central Nervous... Intraocular Lym...	Intraventricula...	18 Years -	University of California, San Francisco
Counting Steps! Integration of Objectively Assessed Physical Activity and Fitness With Smartphones in Clinical Oncology Practice.	NCT03493672	Neoplasms	Objective measu...	18 Years -	Amsterdam UMC, location VUmc
A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma	NCT00221325	Central Nervous... Intraocular Lym...	Intraventricula...	18 Years -	University of California, San Francisco
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations	NCT01752920	Solid Tumor	Derazantinib lo... Derazantinib mi... Derazantinib hi... Derazantinib at...	18 Years -	Basilea Pharmaceutica

Spots Global Cancer Trial Database for phase i clinical trial