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MORAb-202

Phase 2

Neoplasms, Ovarian | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 30, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment106
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05613088A 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 CancerPHASE2 COMPLETED 106Feb 1, 2023Sep 10, 2025Apr 30, 202650 United States, Australia +7
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)

Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose
From first dose of study medication up to 6 months

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.

Secondary Endpoints
Number of Participants With Adverse Events (AEs)
From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Number of Participants With Serious Adverse Events (SAEs)
From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Number of Participants With AEs Leading to Discontinuation
From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MORAb-202EXPERIMENTAL -
Investigator's Choice ChemotherapyEXPERIMENTAL -
Interventions
NameTypeDescription
MORAb-202DRUGSpecified dose on specified days
PaclitaxelDRUGSpecified dose on specified days
Pegylated Liposomal Doxorubicin (PLD)DRUGSpecified dose on specified days
TopotecanDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Female participants with histologically-confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer. * Platinum-resistant disease, defined as: * For participants who had only 1 line of platinum-based therapy: progression between \> 1 month and ≤ 6 months a...

Countries:United StatesAustraliaBelgiumChileIsraelItalyJapanSouth KoreaSpain
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Recent Changes (Last 90 Days)
MEDIUMMay 31, 2026NCT05613088TRIAL_REMOVED: changed
MEDIUMMay 31, 2026NCT05613088TRIAL_REMOVED: changed
MEDIUMMay 31, 2026NCT05613088TRIAL_REMOVED: changed