Health Trials

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

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.

Trial design

Treatments tested in this trial

  • GB-4362
  • enfortumab vedotin (EV)
  • Pembrolizumab

Treatment groups

37 Participants
are divided into 1 treatment group

Locations

10
California
City of Hope91010, Duarte United States
COH Lennar92618, Irvine United States
Florida
Orlando Health32806, Orlando United States
Georgia
COH Atlanta30084, Tucker United States

Sponsors and collaborators

Generate Biomedicines

Lead sponsor

Source ClinicalTrials.gov