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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504111-33-00
Acronym
CA116-001
Enrollment
55
Registered
2024-04-16
Start date
2023-02-14
Completion date
2025-09-10
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Brief summary

1. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Investigator assessment, 2. Occurence of TRAEs leading to discontinuation.

Detailed description

1. Occurrence of the AEs/SAEs, treatment-related AEs/SAEs, AEs leading to discontinuation, AESIs, deaths and laboratory abnormalities, 2. DoR by RECIST v1.1 per investigator Assessment among responders, 3. PFS by RECIST v1.1 per Investigator Assessment

Interventions

DRUGCaelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion
DRUGPACLITAXEL
DRUGTOPOTECAN
DRUGfarletuzumab ecteribulin

Sponsors

Bristol Myers Squibb International Corporation
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Investigator assessment, 2. Occurence of TRAEs leading to discontinuation.—

Secondary

MeasureTime frame
1. Occurrence of the AEs/SAEs, treatment-related AEs/SAEs, AEs leading to discontinuation, AESIs, deaths and laboratory abnormalities, 2. DoR by RECIST v1.1 per investigator Assessment among responders, 3. PFS by RECIST v1.1 per Investigator Assessment—

Countries

Belgium, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026