Farletuzumab Ecteribulin for Solid Cancers

Recruiting in Palo Alto (17 mi)

+41 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Eisai Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

Adults with certain advanced cancers (ovarian, endometrial, lung adenocarcinoma, or triple-negative breast cancer) who have undergone previous treatments and are not currently pregnant or breastfeeding. Participants must have a life expectancy of at least 3 months, good organ function, and no severe heart issues or active infections. They cannot have brain metastases unless specific conditions are met.

Inclusion Criteria

Participants at risk for DVT must have venous Doppler ultrasonography

Participants must have available tumor tissue for FRA expression percent (%) by IHC analysis

Participant must be willing and able to comply with all aspects of the protocol

See 20 more

Exclusion Criteria

Participants with Pulmonary Function Test (PFT) abnormalities

I am not taking any medications that are not allowed with the study treatment.

I have brain metastases but meet specific criteria for treatment.

See 28 more

Treatment Details

Interventions

Corticosteroid (Corticosteroid)
Farletuzumab ecteribulin (Monoclonal Antibodies)
MORAb-202 (Monoclonal Antibodies)

Trial OverviewThe trial is testing Farletuzumab Ecteribulin's safety and effectiveness in different doses for selected tumors. It includes dose-escalation to find the best dose, confirmation of preliminary efficacy in ovarian and endometrial cancers, and optimization to assess other treatment regimens.

Participant Groups

7Treatment groups

Experimental Treatment

Group I: Dose Optimization Part B, Cohort 2: Farletuzumab ecteribulinExperimental Treatment1 Intervention

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

Group II: Dose Optimization Part B, Cohort 1: Farletuzumab ecteribulinExperimental Treatment1 Intervention

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

Group III: Dose Optimization Part A, Cohort 3: Farletuzumab ecteribulinExperimental Treatment1 Intervention

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.

Group IV: Dose Optimization Part A, Cohort 2: Farletuzumab ecteribulinExperimental Treatment1 Intervention

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.

Group V: Dose Optimization Part A, Cohort 1: Farletuzumab ecteribulin + Oral CorticosteroidsExperimental Treatment4 Interventions

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.

Group VI: Dose Escalation Part: Farletuzumab ecteribulinExperimental Treatment1 Intervention

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

Group VII: Dose Confirmation Part: Farletuzumab ecteribulinExperimental Treatment1 Intervention

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