A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors

What this Trial Is About

Researchers are investigating CRB-701, an antibody-drug conjugate targeting nectin-4, in adult patients with advanced solid tumors that express this protein. This three-part, open-label Phase 1/2 trial aims to determine a safe and effective dose of CRB-701 and to understand which cancers might respond to this treatment. The study explores safety, pharmacokinetics, and efficacy to guide future cancer therapies. Participants will receive CRB-701 through intravenous infusion over 30 minutes. The trial includes several dosing groups that range from dose escalation to dose optimization, sometimes combined with an anti-PD-1 drug. Part A focuses on escalating doses to find the maximum tolerated dose, Part B tests dose levels alone or with anti-PD-1 to optimize treatment, and Part C explores the recommended dose in multiple tumor cohorts. During the study, participants will attend clinic visits for infusions and undergo blood tests, CT or MRI scans, and other assessments to monitor tumor response and safety. Researchers will measure the safety, tolerability, and objective response rate to evaluate the treatment’s effect on tumors over periods ranging from 21 days to up to 6 months. The total study duration and monitoring will capture data on efficacy and side effects to support further research.

A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors