Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Micronutrients

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Folic Acid

Vitamin B Complex

Farletuzumab

Folinic Acid

Folate

Vitamin B9

Part 1 (Dose-escalation): The initial dose level of farletuzumab ecteribulin will be 0.3 milligrams per kilogram (mg/kg) every 3 weeks in the first cohort with 1 participant for dose-limiting toxicity (DLT) evaluation. DLTs will be evaluated in successive dose level cohorts with a single participant until a drug-related Grade 2 or higher toxicity is observed. If such a toxicity is observed, the cohort will be expanded to enroll a total of 3 participants.

Part 2 (Treatment Phase): farletuzumab ecteribulin will be administered every 3 weeks during the treatment phase at the dose determined in Part 1 until participants meet any of the criteria for discontinuation. Criteria for discontinuation include: withdrawal of consent, major protocol violations, unable to continue due to adverse events, pregnancy, progressive disease, Investigator decision, or infusion reactions.

Part 1: farletuzumab ecteribulin intravenous (IV) infusion administered every 3 weeks starting at a 0.3 mg/kg dose and successively increasing doses until DLT. Part 2: farletuzumab ecteribulin administered IV every 3 weeks at a dose determined in Part 1 until any of the criteria for discontinuation are met.

Farletuzumab Ecteribulin

The primary objective of this study is to evaluate the tolerability and safety profile of farletuzumab ecteribulin in participants with solid tumors.

This is a Phase 1 study of farletuzumab ecteribulin in participants with solid tumors. This study will be conducted in 2 parts (Part 1 and Part 2). Part 1 will be the dose escalation portion of this study to evaluate dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of farletuzumab ecteribulin in participants with solid tumors. Considering efficacy, safety, and the pharmacokinetic (PK) profile, two doses may be selected from Part 1 for Part 2. Part 2 will comprise cohort expansions to further characterize the safety of farletuzumab ecteribulin and to evaluate the preliminary efficacy of farletuzumab ecteribulin in participants with FRA-positive platinum-resistant ovarian carcinoma and non-small cell lung cancer (NSCLC). The recommended dose for future studies will be determined based on the data from Part 1 and Part 2.

A Study of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin) in Participants With Solid Tumors

A Phase 1 Study of MORAb-202 in Subjects With Solid Tumors

DLTs are defined as the following occurring in Cycle 1 for which a causal relationship with study drug cannot be ruled out: febrile neutropenia, Grade 4 neutropenia persisting for more than 7 days, or neutropenia requiring hematopoietic stimulating agents, Grade 4 thrombocytopenia, or thrombocytopenia requiring platelet transfusion, Grade 4 anemia, or anemia requiring blood transfusion, Grade 3 non-hematological toxicity (except abnormal clinical laboratory values of no clinical significance, any events which can be managed and controlled to Grade 2 or less by maximal medical management, infusion reactions of Grade 3 or higher are NOT considered DLTs because they are stochastic and idiosyncratic events, not related to dose), Grade 4 non-hematological toxicity, and/or when the second treatment with farletuzumab ecteribulin is postponed more than 14 days from the scheduled day due to toxicity. DLTs will be determined by discussion between the investigator, sponsor, and medical expert.

Clinical significance will be determined by the Investigator.

The MTD will be selected as the dose with the smallest difference between the target DLT rate of 25% and an estimate of DLT rate based on the posterior distribution of DLT rate for each dose.

Cmax is the maximum serum concentration of farletuzumab ecteribulin after administration of the drug.

The RD will be determined based on the MTD, efficacy, and safety data in Part 1 and Part 2.

BOR was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). BORs are complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE), where SD has to be achieved at ≥5 weeks after the first dose. CR or PR in Part 1 of this study requires no confirmation of the next response at ≥4 weeks. CR or PR in Part 2 of this study requires confirmation of the next response at ≥4 weeks.

ORR is defined as the percentage of participants with BOR of CR or PR.

DCR is defined as the percentage of participants with BOR of CR, PR, or SD.

CBR is defined as the percentage of participants with BOR of CR, PR or durable (SD) (duration of SD ≥ 23 weeks).

DOR is defined as the time from the first documentation of CR or PR to the first documented date of event (disease progression or death from any cause, whichever occurs first).

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

OS is defined as the time from the date of the first dose to the date of death from any cause. For participants who are alive or unknown, OS is censored as the date of the last known alive date or the date of data cut off, whichever comes first.

Spots Global Cancer Trial Database for A Study of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin) in Participants With Solid Tumors

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