Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Eye Diseases

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Carcinoma

Glioblastoma

Neuroblastoma

Sarcoma

Lung Neoplasms

Retinoblastoma

Virus Diseases

Wilms Tumor

Medulloblastoma

Sarcoma, Ewing

Carcinoid Tumor

Rhabdomyosarcoma

Rhabdomyosarcoma, Alveolar

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Soft Tissue Sarcoma

Wilms' Tumor

Ewing Sarcoma

Rhabdomyosarcoma Alveolar

Neuroendocrine Tumor

Neuroepithelioma

Dose escalation (starting at 1 × 10\^7 vp/kg), IV (in the vein) over 1 hour in a single administration

Seneca Valley Virus (biological agent)

Rudin Charles, MD, PhD

The primary purpose of the study is to determine if Seneca Valley Virus may be administered safely to patients with certain types of advanced cancer.

This is the first study in man of Seneca Valley Virus, a virus which seeks and kills certain tumors in non-human model systems. Subjects in this trial will be patients with advanced cancer displaying certain specified neuroendocrine features, pathologically; they will have exhausted standard methods of treatment for their tumor. The primary purpose of the trial is to determine if the virus may be administered safely. Additional purposes are to learn about the distribution of the virus in the body, the elimination of the virus from the body, the immune response to the virus and whether the virus might have some beneficial effects upon the tumors which the patients have. The first patients will be treated with low amounts of virus and subsequent patients may receive higher amounts. At the end of the trial, it is intended to select a dose for further study.

Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features

Phase I Dose-Escalation Study of Seneca Valley Virus (SVV-001), a Replication-Competent Picornavirus, in Patients With Advanced Solid Tumors With Neuroendocrine Features

Neotropix

Margaret Valnoski, President

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Mesothelioma

Mesothelioma, Malignant

Cystadenocarcinoma, Serous

Adenocarcinoma, Clear Cell

Adenocarcinoma of Lung

Adenomyoepithelioma

Adenocarcinoma, Mucinous

Cystadenocarcinoma

Endometrial Neoplasms

Carcinoma, Endometrioid

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Breast Diseases

Skin Diseases

Adenoma

Neoplasms, Mesothelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplasms, Cystic, Mucinous, and Serous

Ovarian Cancer

Ovarian Epithelial Cancer

Malignant Mesothelioma

Adenocarcinoma of the Appendix

Lung Adenocarcinoma

Epithelial-myoepithelial Carcinoma

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Antibodies

Folic Acid

Immunoglobulins

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

AMT-151

Jane Zhu

Steven Kao

Jermaine Coward

Catherine Shannon

Sarwan Bishnoi

Richardson Gary

Mihitha Ariyapperuma

An Lin, Director

Jing Wang, Director

Jian Zhang, Director

Xiaohua Wu, Director

This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-151, a novel antibody-drug conjugate against folate receptor alpha, in patients with selected advanced solid tumors.

AMT-151 in Patients With Selected Advanced Solid Tumours

First-in-Human, Phase 1 Study of AMT-151, an Anti-Folate Receptor Alpha Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0

Proportion of patients achieving Complete Response (CR) or Partial Response (PR)

Proportion of patients achieving CR, PR or Stable Disease (SD)

Time from date of start of treatment to date of the first progression or death, whichever occurs first.

Time from date of start of treatment to date of the first assessment of response (PR or CR)

Time from date of first assessment of response (CR or PR) to date of the first progression or death, whichever occurs first

Time from date of start of treatment to date of death

Immunogenicity profile characterized by concentration of ADAs

Pharmacokinetic profile characterized by the maximum observed concentration (C\[max\]) of AMT-151

Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-151

Pharmacokinetic profile characterized by the terminal half-life (t\[1/2\]) of AMT-151

Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-151

Tigermed Consulting Co., Ltd

Multitude Therapeutics Inc.

Antineoplastic Agents

Saracatinib

Enzyme Inhibitors

oral, tablet, once daily, dose will be variable

AZD0530

Mary Stuart, MD

Narikazu Boku, MD

This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.

AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours

A Phase I, Open-label, Dose-escalation Study to Assess the Safety and Tolerability of AZD0530 in Patients With Advanced Solid Malignancies

AstraZeneca

Dr Mary Stuart, BSc MSc MB BCh BAO MRCPI, Medical Science Director Emerging Oncology Product Team 1

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pemetrexed

Cisplatin

Aflibercept

Angiogenesis Inhibitors

Growth Inhibitors

Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m\^2) and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.

Administered in combination with the other two interventions via intravenous infusion.

Clinical Trial Management

The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).

The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 was to determine the safest dose of the combined study medications. This dose was administered to patients with previously untreated NSCLC in phase 2. The phase 2 portion of the study determined if the combination is effective in treating NSCLC.

A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma

A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma

Recommended Dose was defined as the highest combination dose at which fewer than 33 percent (%) of participants experienced dose limiting toxicity during the first cycle of therapy.

Objective response rate was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as assessed by modified Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the Baseline sum LD as reference.

PFS was defined as the time in days from the date of first study drug administration to the date of first documentation of tumor progression or death from any cause, whichever occurs first, as assessed by the modified RECIST. Median time of PFS was estimated using Kaplan-Meier method.

An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug. Any TEAE included participants with both serious and non-serious AEs.

The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.

Cmax is the maximum observed plasma concentration obtained directly from the concentration versus time curve.

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

Terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.

Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of ADA.

Sanofi

Regeneron Pharmaceuticals

Reported AEs are treatment-emergent adverse events (TEAEs). A TEAE is an AE that either begins on or after study drug administration or is a pre-existing condition that worsens on or after study drug administration.

Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin

Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin

Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin

Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Clinical Trial Administrator

All participants who received intravenous infusion of aflibercept 2 mg/kg or 4 mg/kg or 6 mg/kg followed by pemetrexed 500 mg/square metere (m\^2) and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Phase 1: All Participants

Full analysis set (FAS) included all participants who were enrolled and received at least one dose of study drug. Data for this outcome measure has been reported for all participants in single arm.

Phase 1: Recommended Dose of Aflibercept for Phase 2

FAS included all participants who were enrolled and received at least one dose of study drug.

Phase 2: Objective Response Rate

Phase 2: Progression-free Survival (PFS)

Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

FAS included all participants who were enrolled and received at least one dose of study drug. Here "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Phase 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Aflibercept

Phase 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Pemetrexed

FAS included all participants who were enrolled and received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable for specific category.

Phase 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Aflibercept and Pemetrexed

FAS included all participants who were enrolled and received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features	NCT00314925	Carcinoid Neuroendocrine	Seneca Valley V...	18 Years -	Neotropix
AMT-151 in Patients With Selected Advanced Solid Tumours	NCT05498597	Advanced Solid ... Advanced Cancer Advanced Carcin... Ovarian Cancer Ovarian Carcino... Ovarian Epithel... Ovarian Endomet... Endometrial Can... Endometrial Ade... Endometrial Ser... Endometrial End... Endometrial Cle... Lung Adenocarci... Triple Negative... Pancreatic Duct... Malignant Pleur... Ovarian Clear C... Ovarian Clear C... Ovarian Mucinou...	AMT-151	18 Years -	Multitude Therapeutics Inc.
Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features	NCT00314925	Carcinoid Neuroendocrine	Seneca Valley V...	18 Years -	Neotropix
AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours	NCT00704366	Solid Tumor	AZD0530	20 Years -	AstraZeneca
A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma	NCT00794417	Advanced Carcin... Non-small Cell ...	Aflibercept Pemetrexed Cisplatin	18 Years -	Regeneron Pharmaceuticals
A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma	NCT00794417	Advanced Carcin... Non-small Cell ...	Aflibercept Pemetrexed Cisplatin	18 Years -	Regeneron Pharmaceuticals

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