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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 initiate, or (for dose escalation only) already receiving, 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 S...
GB-4362 is an investigational small molecule being studied for the treatment of advanced urothelial cancer, including metastatic urothelial carcinoma. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated in combination with enfortumab vedotin and pembrolizumab in a clinical trial.
GB-4362 targets MMAE, a cytotoxic agent commonly used in antibody-drug conjugates. As a neutralizer, GB-4362 is designed to counteract the effects of MMAE, which may help manage toxicity associated with MMAE-based therapies. This mechanism is being studied in the context of advanced urothelial cancer treatment.
GB-4362 is being developed by Generate Biomedicines, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol GENB. Generate Biomedicines is conducting clinical trials to evaluate the safety and efficacy of GB-4362 in patients with advanced urothelial cancer.
GB-4362 is currently 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, which is intended to expedite the development and review of therapies for serious conditions with unmet medical needs.
GB-4362 is being studied in a Phase 1 clinical trial with the identifier NCT07484022. This trial is titled 'Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer' and is currently recruiting participants in the United States. The trial is an open-label, uncontrolled study with an estimated enrollment of 37 patients.
No, GB-4362 is not the same as enfortumab vedotin. GB-4362 is a small molecule that neutralizes MMAE, while enfortumab vedotin is an antibody-drug conjugate that delivers MMAE to cancer cells. In the ongoing clinical trial, GB-4362 is being tested in combination with enfortumab vedotin and pembrolizumab for advanced urothelial cancer.