Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer

Summary

The purpose of this study is to evaluate the safety and tolerability of an investigational drug called GB-4362 when it is given together with enfortumab vedotin and pembrolizumab in adults with advanced or metastatic urothelial cancer. GB-4362 is a monoclonal antibody designed to bind and neutralize free monomethyl auristatin E (MMAE), a chemotherapy payload released from enfortumab vedotin that is associated with side effects such as peripheral neuropathy.

Eligibility

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 Escalation but allowed in Dose Expansion).
* Weight ≥50 kg at screening.
* Life expectancy ≥3 months, as determined by the investigator.
* Participants must provide written informed consent before any study-related activities are carried out and must be able to understand the nature and purpose of the study, including potential risks and adverse effects.
* Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Exclusion Criteria

* Previously received enfortumab vedotin (EV) or other MMAE-based antibody-drug conjugates (ADCs).
* Received anti-cancer treatment with chemotherapy, biologics, or investigational agents within 4 weeks before the first dose of EV/pembrolizumab.
* Uncontrolled diabetes.
* Active CNS metastases. Participants with treated CNS metastases are permitted if all of the following criteria are met:
* CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.
* The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment).
* The participant does not have leptomeningeal disease.
* Ongoing clinically significant toxicity associated with prior treatment (including radiotherapy or surgery) that has not resolved to Grade ≤1 or returned to baseline.
* History of a severe (Grade ≥3) allergic or infusion-related reaction to any monoclonal antibody.
* Another underlying medical condition that, in the opinion of the investigator, would impair the ability of the participant to receive or tolerate the planned treatment and follow-up.
* Known psychiatric or substance abuse disorders that would interfere with cooperating with study requirements

Conditions3

Interventions3

Locations2 sites

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