Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

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.

Eisai Inc.

Symptoms and General Pathology

Adenocarcinoma

Disease Progression

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antibodies

Immunoglobulins

MORAb-202

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of the email MUST contain the NCT# and Site #.

Robert Jotte, Site 0035

Gopal Kunta, Site 0043

Santosh Nair, Site 0010

Steven McCune, Site 0001

Adam Lye, Site 0005

Vinni Juneja, Site 0044

Shirish Gadgeel, Site 0004

John Adams, Site 0034

Enrique Perez, Site 0045

Alexander Spira, Site 0033

Site 0032

Site 0040

Site 0012

Site 0022

Site 0036

Site 0028

Site 0030

Site 0027

Site 0023

Site 0017

Site 0015

Site 0038

Site 0020

Site 0021

Site 0025

Site 0018

Site 0019

Site 0026

Site 0031

Bristol-Myers Squibb

The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.

A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)

A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Fallopian Tube Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endocrine Gland Neoplasms

Ovarian Diseases

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Cancer

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Doxorubicin

Liposomal doxorubicin

Topotecan

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Topoisomerase I Inhibitors

Pegylated Liposomal Doxorubicin (PLD)

Hui Amy Chen, Site 0077

Hui Chen, Site 0065

John Chan, Site 0025

Site 0051

Site 0024

Gregory Gressel, Site 0070

Site 0041

Site 0035

Site 0063

June Hou, Site 0072

Site 0062

Emily Whitman, Site 0061

Melanie Bergman, Site 0042

Sally Baron Hay, Site 0016

Janine Lombard, Site 0017

Jeffrey Goh, Site 0031

Sophia Frentzas, Site 0015

Gary Richardson, Site 0027

Tarek Meniawy, Site 0058

Tarek Meniawy, Site 0075

Site 0060

Pamela Salman Boghikian, Site 0036

Site 0055

Site 0008

Koji Matsumoto, Site 0018

Site 0064

Site 0074

Jae-Weon Kim, Site 0069

Site 0056

Jung-Yun Lee, Site 0049

Site 0057

Site 0066

Jeong Yeol Park, Site 0053

Sara Perez Ramirez, Site 0005

The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.

A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-drug Conjugate, Versus Investigator's Choice Chemotherapy in Women With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Skin and Connective Tissue Diseases

Endometrial Neoplasms

Breast Neoplasms

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Neuroprotective Agents

Dexamethasone

Prednisone

Prednisolone

Dexamethasone acetate

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Participants with selected tumor type will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21 days cycle.

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21 days cycle.

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once on Day 1 and oral corticosteroids on Days 8, 9 and 10 of every 21-day cycle.

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once on Days 1, 8 and 15 of every 21-day cycle.

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once on Days 1 and 8 of every 21-day cycle.

Participants with EC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, at a dosing regimen identified during Part A.

Farletuzumab ecteribulin intravenous infusion.

Farletuzumab ecteribulin

Eisai Medical Information

The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer \[OC\], endometrial cancer \[EC\], non-small cell lung carcinoma \[NSCLC\], triple-negative breast cancer \[TNBC\]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A \[OC and EC participants\] and Part B \[EC only\]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202).

Dose Optimization is randomized part, whereas the Dose Escalation and Dose Confirmation parts are non-randomized.

A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types

A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the investigator assessment of radiologic response according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

DLTs are any of the toxicities occurring during Cycle 1 and assessed by the investigator as related to study drug. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).

AE: as any untoward medical occurrence in a participant administered with an investigational product. SAE: as any untoward medical occurrence that at any dose; resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted incongenital anomaly/birth defect. AEIs are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions. Number of participants with AEIs were reported based on safety assessment of participants with interstitial lung disease (ILD), severity of ILD, time to resolution and onset of ILD symptoms and deaths due to ILD.

DOR is defined as the time from the first date of documented CR or PR to the date of disease progression or death, whichever occurs first. It will be calculated for participants whose BOR is CR or PR. DOR will be assessed according to RECIST version 1.1.

DCR is defined as the percentage of participants with BOR of CR, PR, or stable disease (SD). DCR will be assessed according to RECIST version 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin) in Participants With Solid Tumors	NCT03386942	Solid Tumors	Farletuzumab Ec...	20 Years -	Eisai Inc.
A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)	NCT05577715	Carcinoma, Non-...	MORAb-202	18 Years -	Bristol-Myers Squibb
A Study of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin) in Participants With Solid Tumors	NCT03386942	Solid Tumors	Farletuzumab Ec...	20 Years -	Eisai Inc.
A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer	NCT05613088	Neoplasms, Ovar...	MORAb-202 Paclitaxel Pegylated Lipos... Topotecan	18 Years -	Bristol-Myers Squibb
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types	NCT04300556	Solid Tumor	Farletuzumab ec... Prednisone Prednisolone Dexamethasone	18 Years -	Eisai Inc.

Spots Global Cancer Trial Database for farletuzumab ecteribulin