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GB-4362 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| GB-4362 in Combination With Enfortumab Vedotin and Pembrolizumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GB-4362 | DRUG | GB-4362 is an investigational monoclonal antibody |
| enfortumab vedotin (EV) | DRUG | Enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4 that delivers the cytotoxic payload monomethyl auristatin E (MMAE). |
| Pembrolizumab | DRUG | Pembrolizumab is a programmed death-1 (PD-1) immune checkpoint inhibitor administered as standard-of-care therapy for advanced urothelial cancer. |
Inclusion Criteria * Planned to receive standard-of-care treatment with enfortumab vedotin (EV) (starting dose 1.25 mg/kg) in combination with pembrolizumab for locally advanced or metastatic urothelial cancer. * Age ≥18 years. * ECOG Performance Status score of 0 or 1 (ECOG 2 excluded in Dose Esca...
GB-4362 is an investigational small molecule being developed for the treatment of advanced urothelial cancer, including metastatic urothelial carcinoma. It is currently in Phase 1 clinical development and has not yet been approved by the FDA.
GB-4362 is being developed by Generate Biomedicines, Inc., a biopharmaceutical company traded under the ticker symbol GENB. The company is conducting a Phase 1 clinical trial of GB-4362 in the United States.
GB-4362 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted Fast Track designation by the FDA for the treatment of advanced urothelial cancer.
GB-4362 is being studied in a Phase 1 clinical trial with the identifier NCT07484022. This trial is investigating GB-4362 in combination with enfortumab vedotin and pembrolizumab for advanced urothelial cancer and is currently recruiting participants in the United States.
No, GB-4362 is a distinct investigational small molecule. It is being studied in combination with enfortumab vedotin and pembrolizumab, which are separate drugs, in a Phase 1 clinical trial for advanced urothelial cancer.