Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Dose escalation starting at 6 mg/m2, IV (in the vein) on Day 1 of each 21-day cycle. Number of Cycles: Up to 6 cycles, until unacceptable toxicity, disease progression, or intercurrent illness requires treatment discontinuation. Patients may continue treatment beyond 6 cycles if the Investigator determines that additional treatment would provide further benefit for the patient as long as toxicity remains acceptable.

MBP-426

Alexandria Phan, M.D.

The purpose of this study is to determine whether MBP-426 (liposomal oxaliplatin suspension for injection) is safe and effective in the treatment of advanced or metastatic solid tumors.

Study Phase 1 Study Type (Interventional/Observational) Interventional Study Design Purpose: Treatment Allocation: Nonrandomized trial Masking: Open Control: Dose Comparison Assignment: Single Group Endpoint: Safety/Efficacy

Safety Study of MBP-426 (Liposomal Oxaliplatin Suspension for Injection) to Treat Advanced or Metastatic Solid Tumors

A Phase I, Open Label Study of MBP-426 Given by Intravenous Infusion in Patients With Advanced or Metastatic Solid Tumors

Mebiopharm Co., Ltd

Digestive System Diseases

All Conditions

Hepatic Insufficiency

Liver Failure

Liver Diseases

Gastrointestinal Diseases

Hematinics

Sacituzumab govitecan

Liver Extracts

Immunoconjugates

Immunologic Factors

Participants with advanced solid tumor and moderate hepatic impairment will receive an escalating dose of sacituzumab govitecan-hziy on Days 1 and 8. The dose-escalation plan will start at 5 mg/kg and escalate to 7.5 mg/kg, and finally 10 mg/kg, if deemed to be safe. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198).

Participants with advanced or metastatic solid tumor and normal hepatic function will receive sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198).

Sacituzumab Govitecan-hziy

Gilead Clinical Study Information Center

Gilead Study Director

The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.

Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

A Phase 1, Open-Label, Dose-Escalation Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan in Subjects With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

Cmax will be determined for 4 analytes: Free SN-38, SN-38 glucuronide, Total SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. Cmax is defined as the maximum observed concentration obtained directly from the observed concentration-time data.

AUC_last will be determined for 4 analytes: Free SN-38, SN-38 glucuronide, Total SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. AUC_last is defined as area under the serum concentration-time curve from time 0 to time of the last quantifiable concentration of the 4 analytes.

AUC_0-168 will be determined for 4 analytes: Free SN-38, SN-38 glucuronide, Total SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. AUC0-168 is defined as area under the serum concentration-time curve from time 0 to 168 hours.

Gilead Sciences

BEBT-607 tablets, 100mg/day,50mg each time, are administered once a day in the single administration phase and twice a day in the continuous administration phase (only once on the 28th day of the first cycle) for 28 days. 28 days is as a treatment cycle.

BEBT-607 tablets, 200mg/day,100mg each time, are administered once a day in the single administration phase and twice a day in the continuous administration phase (only once on the 28th day of the first cycle) for 28 days. 28 days is as a treatment cycle.

BEBT-607 tablets, 300mg/day,150mg each time, are administered once a day in the single administration phase and twice a day in the continuous administration phase (only once on the 28th day of the first cycle) for 28 days. 28 days is as a treatment cycle.

BEBT-607 tablets, 400mg/day,200mg each time, are administered once a day in the single administration phase and twice a day in the continuous administration phase (only once on the 28th day of the first cycle) for 28 days. 28 days is as a treatment cycle.

BEBT-607 tablets, 600mg/day,300mg each time, are administered once a day in the single administration phase and twice a day in the continuous administration phase (only once on the 28th day of the first cycle) for 28 days. 28 days is as a treatment cycle.

BEBT-607 tablets, 800mg/day,400mg each time, are administered once a day in the single administration phase and twice a day in the continuous administration phase (only once on the 28th day of the first cycle) for 28 days. 28 days is as a treatment cycle.

BEBT-607 tablets, 300mg/day,150mg each time, are administered twice a day (only once on day 1 and day 28 of the first cycle), continuous administration for 28 days. 28 days is as a treatment cycle.

BEBT-607 tablets, 400mg/day,200mg each time, are administered twice a day (only once on day 1 and day 28 of the first cycle), continuous administration for 28 days. 28 days is as a treatment cycle.

BEBT-607 tablets, 600mg/day,300mg each time, are administered twice a day (only once on day 1 and day 28 of the first cycle), continuous administration for 28 days. 28 days is as a treatment cycle.

PhaseⅠa:100mg,200mg,300mg,400mg,600mg or 800mg/day,50mg,100mg,150mg,200mg,300mg or 400mg each time, once a day in the single administration phase and twice a day in the continuous administration phase (only once on the 28th day of the first cycle) for 28 days,28 days is as a treatment cycle.

PhaseⅠb:300mg,400mg or 600mg/day, 150mg,200mg or 300mg each time,twice a day (only once on day 1 and day 28 of the first cycle), continuous administration for 28 days,28 days is as a treatment cycle.

BEBT-607Tablets

Kegang Jiang, Master

Heli Liu, Ph.D

Zhenhua Liu

This is a two-phase, multicenter, open phase I clinical study, with phase Ia as dose escalation phase and phase Ib as dose expansion phase, to evaluate the safety tolerability and pharmacokinetic characteristics of BEBT-607 tablets in patients with advanced or metastatic solid tumors associated with KRAS G12C mutation. To evaluate the efficacy of BEBT-607 tablets in the treatment of patients with advanced or metastatic solid tumors with KRAS G12C mutation, and to determine the recommended dose (RP2D) for Phase II clinical trials of BEBT-607 tablets in patients with advanced or metastatic solid tumors with KRAS G12C mutation.

Phase Ⅰa:

The dose escalation plan is to carry out about 6 dose levels. The initial dose of BEBT-607 tablets is set at 100mg/ day, and the subsequent dose groups are first increased by 100%. If a case of drug-related grade 2 non-hematological toxicity or grade 3 hematological toxicity is found and does not reach DLT, the subsequent dose groups are increased by 50%. If one case of dose limiting toxicity(DLT) is found and does not reach maximum tolerated dose(MTD ), the subsequent dose group is increased by 33%（Doses are rounded to multiples of 100mg）.The single dose is 1/2 of the total daily dose, and the single administration phase is administered once a day, and the continuous administration phase is administered twice a day (only once on the 28th day of the first cycle).

Phase Ⅰb:

According to the pharmacokinetics, safety and preliminary efficacy results of phase Ⅰa dose escalation phase, one to three cohorts with target dose or tumor species are selected for dose extension trial, and a maximum of 30 subjects are enrolled in each cohort. The subjects receive BEBT-607 tablets twice a day, orally before breakfast and before dinner, respectively. There is a treatment cycle every 28 days (On days 1 and 28 of the first cycle, the drug is administered only once before breakfast). The study process for each subject consisted of three phases: screening, treatment, and follow-up. During treatment, participants are required to undergo safety checks every four weeks from the first dose, tumor assessments every eight weeks, safety follow-up at the end of treatment 28 days after the last dose, efficacy follow-up every eight weeks, and survival follow-up every three months.

Participants will need to understand the requirements and risks of the trial, sign an informed consent form, accept the dosing regimen required by the trial protocol, and follow the investigator's guidance.

Phase Ⅰa:

Six dose levels are carried out, and the initial dose of BEBT-607 tablets is set as 100mg/ day. The climbing study is carried out by accelerated titration method combined with "3+3" mode.

Phase Ⅰb:

According to the pharmacokinetics, safety, and preliminary efficacy results of phase Ⅰa , one to three cohorts with target dose or tumor species are selected for dose extension trial, in which participants receive continuous administration of the experimental drug BEBT-607 tablets until disease progression or toxicity became intolerable or patients stopped or died.

Study of BEBT-607 Tablets in The Treatment of Advanced or Metastatic Solid Tumors With KRAS G12C Mutation

A Two-phase, Multicenter, Open Phase I Study of BEBT-607 Tablets in The Treatment of Advanced or Metastatic Solid Tumors With KRAS G12C Mutation

Area under the plasma concentration time curve from 0 hour to last time of quantifiable concentration after administration

Xiangya Hospital of Central South University

BeBetter Med Inc

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Sarcoma

Lung Neoplasms

Sarcoma, Alveolar Soft Part

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Stomach Cancer

Soft Tissue Sarcoma

Alveolar Soft Part Sarcoma

Bevacizumab

Ramucirumab

Futibatinib

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

AB122 will be given in participants with advanced or metastatic solid tumor.

AB122 will be given in combination with TAS-116 in participants with pancreatic ductal adenocarcinoma.

AB122 will be given in combination with TAS-116 in participants with unresectable metastatic MSS/pMMR CRC without liver metastases.

AB122 will be given in combination with TAS-116 in participants with unresectable metastatic non-squamous NSCLC without actionable gene alterations.

AB122 will be given in combination with TAS-120 in participants with unresectable metastatic NSCLC with PD-L1 high expression and without actionable gene alterations.

AB122 will be given in combination with TAS-115 in participants with unresectable metastatic NSCLC without actionable gene alterations.

AB122 will be given in combination with TAS-115 in participants with unresectable metastatic ASPS, in those who received or no prior regimen for advanced disease.

AB122 will be given in combination with TAS-102 and Ramucirumab in participants with unresectable or recurrent gastric cancer or gastroesophageal junction cancer.

AB122 will be given in combination with TAS-102 and Bevacizumab in participants with unresectable metastatic CRC.

AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes Q3W.

TAS-116 will be administered orally in 5-day on and 2-day off schedule on an empty stomach at least 1 hour before or 2 hour after eating.

TAS-116

AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.

TAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.

TAS-120

TAS-115 will be administered orally in 5-day on and 2-day off schedule on an empty stomach at least 1 hour before or 2 hours after eating.

TAS-115

AB122 will be administered with 240 mg/body given by infusion over 60 minutes every 2 weeks.

TAS-102 will be administered orally twice daily at a dose calculated based on body surface area (BSA) within 1 hour after morning and evening meals for 5 days, a week with 2 days rest for 2 weeks, followed by a 14-day rest, repeated every 4 weeks.

TAS-102

Ramucirumab will be administered by infusion at a dose calculated using the body weight over approximately 60 minutes every 2 weeks.

TAS-102 will be administered orally twice daily at a dose calculated based on BSA within 1 hour after morning and evening meals for 5 days, a week with 2 days rest for 2 weeks, followed by a 14-day rest, repeated every 4 weeks.

Bevacizumab will be administered by infusion at a dose calculated using the body weight over approximately 90 minutes every 2 weeks.

Drug Information Center

Taiho Pharmaceutical Co., Ltd.

This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.

AB122 Platform Study

Platform Study of AB122 Based Treatments in Patients With Advanced Solid Tumors

Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html.

Advanced or metastatic solid tumors harboring FGFR1-4 rearrangements

Advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification

Myeloid or lymphoid neoplasm harboring FGFR1 rearrangement

Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle

The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma \[iCCA\]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.

Study TAS-120-202 is an open-label, multinational, 3-arm Phase 2 study evaluating the efficacy, safety, tolerability, PK, and pharmacodynamics of futibatinib in patients with FGFR aberrations. Eligible patients will be assigned to 1 of 3 treatment cohorts based on diagnosis and FGFR gene aberration status.

Patients will receive futibatinib at an oral dose of 20 mg once a day on a continuous 28-day cycle.

The study will enroll approximately:

* Cohort A: 60 patients with locally advanced, advanced, or metastatic solid tumor harboring FGFR rearrangements other than primary brain tumor or iCCA;
* Cohort B: 35 patients with locally-advanced, advanced, or metastatic gastric cancer or gastro-esophageal junction (GEJ) with FGFR2 amplification;
* Cohort C: 20 patients with myeloid or lymphoid neoplasms (MLN) with FGFR1 rearrangements

Treatment in all cohorts will continue until disease progression, unacceptable toxicity, or any other of the criteria for treatment discontinuation is met. For patients who discontinue treatment for reasons other than disease progression, tumor assessments should be continued until radiologic disease progression is documented or until initiation of subsequent new anticancer therapy (whichever occurs first).

Patients will be followed for survival every 12 weeks (±2 weeks) until survival events (deaths) have been reported for 75% of enrolled patients or the study is terminated early by the Sponsor.

Additional cohorts may be added in the future in case of new emerging efficacy data.

The study consists of independent 3 cohorts (Cohorts A, B and C) and there is no difference in the treatment regimen between the cohorts

Futibatinib in Patients With Specific FGFR Aberrations

A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations

ORR, defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on independent central review of radiological images.

CR rate, defined as the proportion of patients who achieved a CR (per response criteria for MLN) based on investigators' assessment of imaging, peripheral blood, and bone marrow.

ORR, defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment.

DOR, defined as the time from the first documentation of response (CR or PR in Cohorts A and B; CR, PR, or CRi in Cohort C) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.

PFS, defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression, whichever occurs first.

OS, defined as the time from the date of first dose to the death date.

DCR, defined as the proportion of patients experiencing a best overall response of stable response (SD), PR, or complete response (CR) (per RECIST 1.1).

CR+CRi rate, defined as the proportion of patients who achieved a CR or CRi

Duration of CR, defined as the time from the first documentation of CR to the first documentation of recurrence or death due to any cause, whichever occurs first.

Duration of CR+CRi, defined as the time from the first documentation of CR or CRi to the first documentation of disease relapse or death due to any cause, whichever occurs first.

CCyR rate, defined as the proportion of patients who achieved a CCyR

PCyR rate, defined as the proportion of patients who achieved a PCyR

RFS, defined as the time from first documentation of CR to the date of death (any cause) or disease relapse or death due to any cause, whichever occurs first

EFS, defined as the time from first dose of study therapy to treatment failure, disease relapse after CR, or patient death due to any cause, whichever occurs first

Safety based on reported AEs will be graded according to the National Cancer Institute- Common Terminology Criteria for Adverse events (NCI-CTCAE), Version 5.0.

Taiho Oncology, Inc.

Blood and Lymph Conditions

Behaviors and Mental Disorders

Hematologic Neoplasms

Hematologic Diseases

Quality of Life

Patients treated with anti-cancer oral therapy who benefit a specific pharmaceutical follow-up by the healthcare facilities pharmacist and by the dispensary pharmacist

Patients treated with anti-cancer oral therapy who who do not benefit from an additional pharmaceutical intervention

The coordinated experimental pharmaceutical path consists of 7 pharmaceutical interviews or consultations. One initial pharmaceutical consultation with the hospital pharmacist. Five follow-up pharmaceutical interviews with the dispensary pharmacist. One follow-up pharmaceutical consultation with hospital pharmacist.

Each pharmaceutical interview or consultation will result in the drafting of a pharmaceutical report to be sent to the other participating health professionals. At each pharmaceutical consultation or interview, the pharmacists requested perform a clinical pharmaceutical analysis of drug prescriptions; Evaluate the patient's understanding; Detect adherence problems, Identify drug related problems; Alert the oncologist and / or the attending physician.

IPPACTTO

Fanny D'ACREMONT-JUTIER

Emilie DEBEAUPUIS

Elouen BOUGHALEM, MD

Mathilde HUNAULT Mathilde, MD

Victor SIMMET, MD

Nadine MORINEAU Nadine, MD

Oana COJOCARASU, MD

Nicolas BLIN, MD

Emmanuelle BOURBOULOUX, MD

The rise of oral therapies in the management of cancers has considerably changed the patient care path. If the oral route is preferred by patients because it offers a better quality of life, it is not without impact for patients and the health professionals involved in their management in their care. Indeed, the use of the oral route shifts part of the responsibility for monitoring treatment towards the patient, thereby leading to compliance problems, drug interactions and the management of adverse effects.These risks can cause complications or compromise the effectiveness of treatment, and generate additional costs for the investigator's health system. The study proposes to involve Healthcare Facilities Pharmacist and the Dispensary Pharmacist with all other health professionals.First, the hospital pharmacist will operate before the initiation of an oral route to perform a clinical pharmaceutical analysis of drug prescriptions. Then after the primary prescription and finally during a follow-up consultation 3 months after the initiation of treatment. The hypothesis of the study is that the coordinated intervention of the hospital pharmacist and of the dispensary pharmacist would improve the tolerance of oral treatments by reducing the number of serious adverse effects found, as well as improve the, quality of life, patient and professional satisfaction

Impact of the Coordinated Intervention of the Healthcare Facilities Pharmacist and the Dispensary Pharmacist on the Care Pathway for Cancer Patients Treated With Oral Therapy

Pharmaceutical Intervention in the Coordinated Care Pathway for Cancer Patients Treated With Oral Therapy

The impact on tolerance will be measured by the proportion of patients with at least one grade 3 or 4 adverse event occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.

The impact will be measured by the number of grade 3 and 4 adverse events occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.

Number of unplanned hospitalizations related to the oral therapy and confirmed by the oncologist.

Number and nature of potential and confirmed drug related problemS detected by pharmacists

Number of treatment modifications related to oral therapy, necessary before starting treatment and during oral therapy and confirmed by the oncologist during follow-up consultations

Quality of life for patients will be evaluated by a questionnaire before and after starting oral therapy according to the The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

Adherence to the oral therapy measured with the Girerd questionnaire wich is composed of 6 questions with an expected answer yes or no. A "yes" answer is worth 1, "No" answer is worth 0. The maximum score obtained is 6; the minimum score is 0. Final Score\> 2: low compliance ; Final score = 1 or 2: average compliance ; Final score = 0: good compliance.

Satisfaction of patients will be evaluated by a series of questions related to oral therapy. The patient responds if he strongly disagrees; rather disagree; somewhat agree ; Totally agree. An overall score is also required between 1 and 10; 1 is very bad; 10 is perfect

Evaluation of the link will be performed by a questionnaire to be completed by the oncologist and pharmacists. Each responds if he strongly disagrees; rather disagree; somewhat agree ; Totally agree

Institut Cancerologie de l'Ouest

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Dose escalation phase: The patients confirming to the eligibility criteria will be assigned to the 6 dose groups (0.01mg/kg, 0.03mg/kg, 0.1mg/kg, 0.2mg/kg, 0.3mg/kg 0.45mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL97 every 3 week on Day 1 of each cycle. Additional 1 or 2 dose cohorts will receive an intravenous infusion of MIL97 every 2 week on Day 1 of each cycle after last patient finishes DLT observation period.

Dose expansion phase: One or two recommended expansion doses (either Q3W or Q2W) will be selected from 6 dose groups (0.01mg/kg, 0.03mg/kg, 0.1mg/kg, 0.2mg/kg, 0.3mg/kg 0.45mg/kg) based on results of dose escalation phase. MIL97 will be administered via intravenous infusion for 60 to 90 minutes on Day 1 of each cycle.

Recombinant Humanized Monoclonal Antibody MIL97 for Injection

Jianming Xu, Ph.D

Jianming Xu, doctor

This is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in subjects with advanced or metastatic solid tumor. The study consists of a dose escalation phase and a dose expansion phase. An accelerated titration design (cohorts 1-2 only) followed by 3+3 dose-escalation design will be used in dose escalation phase.

The starting dose for dose escalation phase is 0.01 mg/kg Q3W, followed by 5 dose cohorts (0.03mg/kg Q3W, 0.1mg/kg Q3W, 0.2mg/kg Q3W, 0.3mg/kg Q3W and 0.45mg/kg Q3W). Duration of dose limiting toxicity (DLT) observation is 21 days. Based on data of 3-week treatment regimen, one or two dose levels may be chosen for Q2w regimen. Duration of dose limiting toxicity (DLT) observation is 28 days.

One or two dose cohorts will be chosen (either 2-week regimen or 3-week regimen cohorts) to expand to total of 10 subjects in each cohort for further exploration of PK as well as safety and efficacy.

Treatment of Advanced and Metastatic Solid Tumors With MIL97

A Phase I Multicenter, Open Label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MIL97 in Subjects With Advanced or Metastatic Solid Tumors

incidence of AEs and SAEs assessed by NCI CTCAE v5.0.

The area under the curve (AUC) of serum concentration of the drug after the administration

Maximum concentration (Cmax) of the drug after administration

To evaluate preliminary anti-tumor activity of MIL97 in subjects with advanced or metastatic solid tumor. ORR includes complete remission (CR) and partial remission (PR) assessed by RECIST v1.1 criteria.

DOR is defined as the time from the initial response (CR or PR) to the time of disease progression or death, whichever occurs first.

Defined as the time from the first day of study treatment to disease progression or death, whichever occurs first.

Defined defined as the proportion of patients with objective evidence of CR, PR, or SD.

Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL97.

measurement of CD80, CD86 and cytokines in human plasma

Beijing Mabworks Biotech Co., Ltd.

Mitogens

Dose escalation:

The starting dose of the combination will be escalated in a stepwise fashion, escalating one drug at a time.

Dose expansion (urothelial cancer):

Patients in the dose expansion will be treated with the combination identified in the dose escalation part of the study.

Dose escalation:

Starting dose is rogaratinib 400 mg twice daily (b.i.d.) in continuous 28-day cycles from Cycle 1 Day 3 onwards.

Dose expansion:

With dose identified in dose escalation part.

Rogaratinib (BAY1163877)

Dose escalation:

Starting dose is 45 mg on Days 1, 8 and 15 of each 28-day cycle.

Dose expansion:

With dose identified in dose escalation part.

Copanlisib (BAY80-6946)

The primary objective of this study is to determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and efficacy of rogaratinib in combination with copanlisib in patients with locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype.

The secondary objectives of this study are to characterize the pharmacokinetics (PK) of rogaratinib and copanlisib alone and in combination, and to assess the anti-tumor efficacy of rogaratinib in combination with copanlisib for locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype.

Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors

A Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the Combination of Rogaratinib and Copanlisib in Patients With FGFR-positive, Locally Advanced or Metastatic Solid Tumors

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

ORR in patients receiving the recommended dose of the rogaratinib-copanlisib-combination during the dose expansion part

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of MBP-426 (Liposomal Oxaliplatin Suspension for Injection) to Treat Advanced or Metastatic Solid Tumors	NCT00355888	Cancer	MBP-426	18 Years -	Mebiopharm Co., Ltd
Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment	NCT04617522	Advanced or Met... Liver Failure	Sacituzumab Gov...	18 Years -	Gilead Sciences
Study of BEBT-607 Tablets in The Treatment of Advanced or Metastatic Solid Tumors With KRAS G12C Mutation	NCT06117371	Advanced or Met... KRAS G12C Mutat...	BEBT-607Tablets	18 Years -	BeBetter Med Inc
AB122 Platform Study	NCT04999761	Advanced or Met... Pancreatic Duct... Colorectal Canc... Non-small Cell ... Gastric Cancer Alveolar Soft P...	AB122 AB122 AB122 TAS-116 AB122 TAS-116 AB122 TAS-116 AB122 TAS-120 AB122 TAS-115 AB122 TAS-115 AB122 TAS-102 Ramucirumab AB122 TAS-102 Bevacizumab	18 Years -	Taiho Pharmaceutical Co., Ltd.
Futibatinib in Patients With Specific FGFR Aberrations	NCT04189445	Advanced or Met... Advanced or Met... Myeloid or Lymp...	Futibatinib	18 Years -	Taiho Oncology, Inc.
Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment	NCT04617522	Advanced or Met... Liver Failure	Sacituzumab Gov...	18 Years -	Gilead Sciences
AB122 Platform Study	NCT04999761	Advanced or Met... Pancreatic Duct... Colorectal Canc... Non-small Cell ... Gastric Cancer Alveolar Soft P...	AB122 AB122 AB122 TAS-116 AB122 TAS-116 AB122 TAS-116 AB122 TAS-120 AB122 TAS-115 AB122 TAS-115 AB122 TAS-102 Ramucirumab AB122 TAS-102 Bevacizumab	18 Years -	Taiho Pharmaceutical Co., Ltd.
Impact of the Coordinated Intervention of the Healthcare Facilities Pharmacist and the Dispensary Pharmacist on the Care Pathway for Cancer Patients Treated With Oral Therapy	NCT04327583	Advanced or Met... Relapsed Hemato...	IPPACTTO	18 Years -	Institut Cancerologie de l'Ouest
Treatment of Advanced and Metastatic Solid Tumors With MIL97	NCT04965077	Advanced or Met...	Recombinant Hum...	18 Years -	Beijing Mabworks Biotech Co., Ltd.
Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors	NCT03517956	Advanced or Met...	Rogaratinib (BA... Copanlisib (BAY...	18 Years -	Bayer

Spots Global Cancer Trial Database for advanced or metastatic solid tumor