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GB-5267 - only

Phase 1

Platinum-resistant Ovarian Cancer | Monoclonal antibody | Oncology |Generate Biomedicines, Inc.|Last Updated: Mar 27, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07489287GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube CancerPHASE1 NOT YET_RECRUITING 18Jun 15, 2026Jan 15, 2030Mar 27, 2026 -
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07489287studyFirstPostDate: changed