Phase 1 Study to Assess Safety and Effects of AB521 Alone and With Other Drugs in Advanced Clear Cell Renal Cell Carcinoma and Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of casdatifan, alone and in combination with other drugs, in participants with advanced solid tumors and clear cell renal cell carcinoma ccRCC. The study includes two stages a dose escalation stage for various solid tumors and a dose expansion stage specifically for ccRCC. This phase 1 trial aims to understand how these treatments affect patients and to find safe dosage levels. Participants receive casdatifan orally once or twice daily. In the dose expansion stage, casdatifan is studied alone or combined with cabozantinib, zimberelimab, or zimberelimab plus ipilimumab. These medications are given orally or by infusion depending on the combination. Treatment dosing and combinations vary by study arm, reflecting different cohorts. The study is open-label and non-randomized. During the trial, participants undergo regular monitoring for dose-limiting toxicities and adverse events over up to 4 months. Researchers measure tumor response using established criteria and assess plasma levels of casdatifan to understand its behavior in the body. The study tracks pharmacokinetic data and safety outcomes. Participants are observed throughout treatment with frequent visits and assessments to evaluate effects and tolerability.

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors