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GB-5267

Phase 1

Platinum-resistant Ovarian Cancer | Monoclonal antibody | Oncology |Generate Biomedicines, Inc.|Last Updated: Mar 27, 2026

Target and mechanism

Molecular targetMUC16
ModalityMonoclonal antibody

Also known as GB-5267 - IV only, GB-5267- only, GB-5267 -Combined IV and IP Infusion, GB-5267-Combined and IP Infusion

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

GB-5267 · 1 trial · 1 indication

Phase 1 1
NCT07489287GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube CancerPlatinum-resistant Ovarian Cancer
NOT YET_RECRUITING18 Analytics
PHASE1NOT YET_RECRUITING
GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer
Platinum-resistant Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose (MTD) - Cohort A
28 days from GB-5267 cell infusion

Determine the MTD by assessing the incidence of dose limiting toxicities (DLTs) of GB-5267

Number of DLTs in combined IV and IP infusions of GB-5267 - Cohort B
Day 0 through day 7 after GB-5267 infusion

Evaluated using the Clopper-Pearson method

Secondary Endpoints

Time to Response - Cohort A
From start of treatment to first observation of overall response -Up to 2 years
Time to Response - Cohort B
Up to 2 years
Duration of Response - Cohort A
From time of overall response to disease progression or death -Up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IV OnlyEXPERIMENTALPatients receive IV only infusion of GB-5267 cells
Dose Expansion with Combined IV and IP InfusionEXPERIMENTALA combined administration of both IV and IP infusions.

Interventions

NameTypeDescription
GB-5267 - IV onlyBIOLOGICALIV infusion
GB-5267 -Combined IV and IP InfusionBIOLOGICALIV and IP Infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * At least 18 years of age * Patients must have epithelial ovarian, peritoneal, or fallopian tube cancer that is confirmed by histology or cytology, with a histopathological diagnosis of serous, clear cell, endometrioid, mucinous carcinoma, or carcinosarcoma. * Must have platinu...

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Frequently asked questions about GB-5267

What is GB-5267 used for?

GB-5267 is an investigational monoclonal antibody being developed for the treatment of platinum-resistant ovarian cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does GB-5267 target?

GB-5267 targets MUC16, a protein associated with ovarian cancer. By binding to MUC16, the antibody is designed to interfere with tumor cell activity, though the exact mechanism is still under investigation in clinical trials.

Who is developing GB-5267?

GB-5267 is being developed by Generate Biomedicines, Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and efficacy in patients with platinum-resistant ovarian cancer.

What phase is GB-5267 in?

GB-5267 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and effectiveness.

What clinical trials is GB-5267 in?

GB-5267 is being studied in a Phase 1 clinical trial with the identifier NCT07489287. This trial is designed to evaluate the drug in patients with platinum-resistant ovarian, peritoneal, or fallopian tube cancer and is not yet recruiting participants.

Is GB-5267 the same as GB-5267 - IV only?

Yes, GB-5267 is also known as GB-5267 - IV only, indicating that the drug is administered intravenously. This alternative name is used in clinical trial documentation to specify the route of administration.