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

NCT07489287 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: I-4601225
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Platinum-resistant Ovarian Cancer

Keywords

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD) - Cohort A

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

  28 days from GB-5267 cell infusion

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

  Evaluated using the Clopper-Pearson method

  Day 0 through day 7 after GB-5267 infusion

Secondary Outcomes (8)

• 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

• Duration of Response - Cohort B

  rom time of overall response to disease progression or death -Up to 2 years

• Time to disease Progression - Cohort A

  From date of start of treatment too date of first documented progression, up to 2 years

Study Arms (2)

IV Only

EXPERIMENTAL

Patients receive IV only infusion of GB-5267 cells

Biological: GB-5267 - IV only

Dose Expansion with Combined IV and IP Infusion

EXPERIMENTAL

A combined administration of both IV and IP infusions.

Biological: GB-5267 -Combined IV and IP Infusion

Interventions

GB-5267 - IV only BIOLOGICAL

IV infusion

IV Only

GB-5267 -Combined IV and IP Infusion BIOLOGICAL

IV and IP Infusion

Dose Expansion with Combined IV and IP Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Generate Biomedicines: collaborator

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Emese Zsiros, MD, PhD

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ask RPCI

CONTACT

716-845-2300; askroswell@roswellpark.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 24, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2030
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (1)