NCT07489287
GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentRoswell Park Cancer InstituteInvestigator-initiated
~18 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:GB-5267 - IV onlyGB-5267 -Combined IV and IP Infusion
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD) - Cohort A
Measured over 28 days from GB-5267 cell infusion
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Emese Zsiros, MD, PhD · PRINCIPAL_INVESTIGATOR · Roswell Park Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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:
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:
Adequate hematological function, including:
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:
Life expectancy of at least 3 months without treatment.
Participant must be willing to undergo core or excisional biopsy of a tumor lesion
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,
Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion
Coagulation Abnormalities and Hemorrhage:
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. 3. 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.
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.
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:
Pulmonary and Third-Space Fluid:
Any serious, uncontrolled medical condition (e.g., cirrhotic liver disease, recent significant trauma, or severe psychiatric illness) that, in the opinion of the Investigator, could compromise participant safety or the interpretation of study data.
Prior or Concurrent Therapies:
Live Vaccine Administration:
Infectious Disease (HIV, Hepatitis): 2. Active or inadequately controlled hepatitis A, B, or C infection:
What this trial measures
- Maximum Tolerated Dose (MTD) - Cohort A28 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 BDay 0 through day 7 after GB-5267 infusion
Evaluated using the Clopper-Pearson method