Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenerate Biomedicines
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 groupSponsors and collaborators
Source ClinicalTrials.gov