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MORAb-202

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment106

FDA Designations

No designations recorded

Clinical trial landscape

MORAb-202 · 1 trial · 1 indication

Phase 2 1
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 CancerNeoplasms, Ovarian
COMPLETED106 Analytics
PHASE2COMPLETED
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
Neoplasms, Ovarian
NCT05613088106
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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 to 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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Frequently asked questions about MORAb-202

What is MORAb-202 used for?

MORAb-202 is an investigational small molecule being studied for the treatment of ovarian neoplasms, specifically platinum-resistant high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who is developing MORAb-202?

MORAb-202 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain gynecologic cancers.

What phase is MORAb-202 in?

MORAb-202 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in a completed Phase 2 trial for platinum-resistant high-grade serous ovarian cancer.

What clinical trials is MORAb-202 in?

MORAb-202 has one completed Phase 2 clinical trial registered under NCT05613088. This study compared MORAb-202 to investigator's choice chemotherapy in female participants with platinum-resistant high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. The trial enrolled 106 participants across multiple countries.

Is MORAb-202 the same as any other drug?

No alternative names for MORAb-202 have been reported. It is identified solely by its code name MORAb-202 in clinical trial registrations and scientific literature. The drug is a distinct investigational agent being developed by Bristol-Myers Squibb.