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

Recruiting now · Phase 1

Conditions studied: Platinum-resistant Ovarian Cancer

In brief

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

Key facts

Study ID

NCT07489287

Run by

Roswell Park Cancer Institute

People needed

18

Starts

2026-07-15

Expected to finish

2030-01-15

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 platinum-resistant disease, defined as:
• Progression of disease within 6 months of last platinum-based chemotherapy, OR
• Patients who have an intolerance for further platinum-based therapy.
• CA125 > 2 x ULN as assessed at the local lab by a 501(k) cleared test at Screening.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Must have evaluable disease or measurable disease defined as:
• a. Measurable lesion as per RECIST v1.1 criteria
• Adequate hematological function, including:
• Absolute neutrophil count (ANC) > 1,000/mm3
• Platelet count > 50,000/mm3
• Hemoglobin > 8.5 g/dL
• Adequate renal function, including estimated creatinine clearance > 60 mL/min (Cockcroft-Gault) or directly measured with a 24-hour urine collection test.
• Adequate liver function, including:
• 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.
• Life expectancy of at least 3 months without treatment.
• Participant must be willing to undergo core or excisional biopsy of a tumor lesion
• A pretreatment biopsy must be obtained following completion of screening procedures and at least 7 days prior to the cell infusion.
• An on-treatment biopsy must be performed on Day 28 (±5 days) after infusion.
• An end-of-treatment biopsy must be performed within 10 days of disease progression or any other reason for discontinuation.
• Individuals of child-bearing potential (ICBP), defined as a sexually mature individual who has not undergone a hysterectomy, bilateral oophorectomy, or tubal ligation, or who has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months,
• Must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test, as verified by the Investigator, at Screening and Baseline.
• Must agree to abstain from breastfeeding during study participation and for at least 1 year post-GB-5267 infusion.

You may not qualify if…

• Coagulation Abnormalities and Hemorrhage:
• Recent significant bleeding, defined as a history of Grade ≥2 hemorrhage within 30 days before Screening.
• Coagulation parameters (assessed at Screening):
• Activated partial thromboplastin time (aPTT) >1.5 × ULN. Exception: Participants on therapeutic heparin may be allowed if aPTT is between 1.5 and 2.5 × ULN.
• International Normalized Ratio (INR) >1.5. Exception: Participants on warfarin are allowed if INR is between 2.0 and 3.0 on two consecutive measurements taken 1-4 days apart.
• 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 or evidence of thrombotic or hemorrhagic disorders within 3 months prior to Screening, including cerebrovascular accident (CVA) / stroke, transient ischemic attack (TIA), or subarachnoid hemorrhage.
• Known history or presence of clinically relevant CNS pathology (e.g., untreated or active brain metastases, epilepsy requiring ongoing treatment, stroke or subarachnoid hemorrhage within 3 months, severe neurodegenerative disorders, or psychosis).
• Active or clinically significant autoimmune disease requiring systemic immunosuppression (e.g., >10 mg/day prednisone equivalent or other immunosuppressants) within the past 6 months.
• Exception: Patients with stable, well-controlled autoimmune conditions, including but not limited to:
• Type 1 Diabetes Mellitus on stable insulin therapy
• Hypothyroidism managed with hormone replacement
• Vitiligo
• Resolved childhood asthma
• Patients on low-dose immunosuppressants (≤10 mg/day prednisone equivalent) without recent exacerbations
• Other non-systemic autoimmune conditions deemed low risk at the Principal Investigator's (PI) discretion
• Any treatment-related immune-mediated AEs from previous immunotherapy that have not resolved to baseline or Grade ≤1 at least 3 months prior to enrollment.
• Ongoing systemic bacterial, viral, or fungal infection not improving despite appropriate antimicrobial therapy, or requiring intravenous (IV) antimicrobials at Screening. Participants receiving prophylactic antimicrobials are eligible if there is no active infection.
• Any other active malignancy within 2 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ (e.g., cervix, breast).
• Need for urgent intervention due to tumor mass effects (e.g., bowel obstruction or major vascular compression) that would preclude protocol compliance.
• Cardiac-Related Exclusions:
• 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).

Where it is running

• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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