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Also known as GB-5267 - IV only, GB-5267- only
GB-5267 · 1 trial · 1 indication
Determine the MTD by assessing the incidence of dose limiting toxicities (DLTs) of GB-5267
Evaluated using the Clopper-Pearson method
| Arm | Type | Description |
|---|---|---|
| IV Only | EXPERIMENTAL | Patients receive IV only infusion of GB-5267 cells |
| Dose Expansion with Combined IV and IP Infusion | EXPERIMENTAL | A combined administration of both IV and IP infusions. |
| Name | Type | Description |
|---|---|---|
| GB-5267 - IV only | BIOLOGICAL | IV infusion |
| GB-5267 -Combined IV and IP Infusion | BIOLOGICAL | IV and IP Infusion |
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...
GB-5267 is being developed for the treatment of platinum-resistant ovarian cancer, a form of ovarian cancer that has progressed after platinum-based chemotherapy. It is also being studied in platinum-resistant peritoneal and fallopian tube cancers, which are closely related gynecologic malignancies often grouped with ovarian cancer in clinical trials.
GB-5267 targets MUC16, a protein also known as CA125 that is commonly overexpressed on the surface of ovarian cancer cells. By binding to MUC16, this monoclonal antibody is designed to direct an immune response against MUC16-expressing tumor cells in platinum-resistant ovarian, peritoneal, and fallopian tube cancers.
GB-5267 is being developed by Generate Biomedicines, Inc., a biotechnology company focused on generative protein design. The company trades under the ticker symbol GENB. Generate Biomedicines is the sole developer listed for this monoclonal antibody candidate.
GB-5267 is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The Phase 1 trial is designed to evaluate the drug in patients with platinum-resistant ovarian, peritoneal, or fallopian tube cancer.
GB-5267 is being evaluated in one active Phase 1 clinical trial, NCT07489287, titled "GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer." The trial has a planned enrollment of 18 participants, is controlled, and is not yet recruiting. It is open to adults 18 years and older of all sexes.