Not Yet RecruitingPhase 1

GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer

18 participantsStarted 2026-06-15

Plain-language summary

This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Progression of disease within 6 months of last platinum-based chemotherapy, OR
✓. Patients who have an intolerance for further platinum-based therapy.
✓. Absolute neutrophil count (ANC) \> 1,000/mm3
✓. Platelet count \> 50,000/mm
✓. Hemoglobin \> 8.5 g/dL
✓. Total bilirubin \< 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin \< 3 x ULN
✓. Aspartate and alanine aminotransferase (AST and ALT) \< 3 x ULN; \< 5 x ULN if there is liver involvement by the tumor.
✓. A pretreatment biopsy must be obtained following completion of screening procedures and at least 7 days prior to the cell infusion.

✕. Recent significant bleeding, defined as a history of Grade ≥2 hemorrhage within 30 days before Screening.
✕. Coagulation parameters (assessed at Screening):
✕. Anticoagulant use: Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes is excluded. Prophylactic anticoagulation (e.g., low-molecular-weight heparin \[LMWH\] 40 mg/day) or use of anticoagulants for venous access device patency is permitted if the participant has been on a stable dose for ≥4 weeks without bleeding complications.
✕. History of Class III or IV congestive heart failure, non-ischemic cardiomyopathy, unstable or poorly controlled angina, or peripheral arterial disease event within 6 months prior to enrollment.
✕. Echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) \<40%.
✕. Previous myocardial infarction within 1 year prior to Screening.
✕. Clinically significant arrhythmia (e.g., second- or third-degree AV block, paroxysmal atrial fibrillation requiring active treatment, or prior pacemaker/defibrillator placement).
✕. Any history of myocarditis.

Maximum Tolerated Dose (MTD) - Cohort A

Timeframe: 28 days from GB-5267 cell infusion

Number of DLTs in combined IV and IP infusions of GB-5267 - Cohort B

Timeframe: Day 0 through day 7 after GB-5267 infusion

NCT IDNCT07489287

SponsorRoswell Park Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-15

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Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Progression of disease within 6 months of last platinum-based chemotherapy, OR
✓. Patients who have an intolerance for further platinum-based therapy.
✓. Absolute neutrophil count (ANC) \> 1,000/mm3
✓. Platelet count \> 50,000/mm
✓. Hemoglobin \> 8.5 g/dL
✓. Total bilirubin \< 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin \< 3 x ULN
✓. Aspartate and alanine aminotransferase (AST and ALT) \< 3 x ULN; \< 5 x ULN if there is liver involvement by the tumor.
✓. A pretreatment biopsy must be obtained following completion of screening procedures and at least 7 days prior to the cell infusion.

✕. Recent significant bleeding, defined as a history of Grade ≥2 hemorrhage within 30 days before Screening.
✕. Coagulation parameters (assessed at Screening):
✕. Anticoagulant use: Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes is excluded. Prophylactic anticoagulation (e.g., low-molecular-weight heparin \[LMWH\] 40 mg/day) or use of anticoagulants for venous access device patency is permitted if the participant has been on a stable dose for ≥4 weeks without bleeding complications.
✕. History of Class III or IV congestive heart failure, non-ischemic cardiomyopathy, unstable or poorly controlled angina, or peripheral arterial disease event within 6 months prior to enrollment.
✕. Echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) \<40%.
✕. Previous myocardial infarction within 1 year prior to Screening.
✕. Clinically significant arrhythmia (e.g., second- or third-degree AV block, paroxysmal atrial fibrillation requiring active treatment, or prior pacemaker/defibrillator placement).
✕. Any history of myocarditis.