NCT05536141

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

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 362 (estimated)
• Sponsor: Arcus Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

Conditions

• Clear Cell Renal Cell Carcinoma
• Solid Tumors

Interventions

Type	Name	Description
DRUG	casdatifan	Administered as specified in the treatment arm
DRUG	Cabozantinib	Administered as specified in the treatment arm
DRUG	Zimberelimab	Administered as specified in the treatment arm
DRUG	Ipilimumab	Administered as specified in the treatment arm

Timeline

• Start date: 2022-10-26
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2022-09-10
• Last updated: 2026-03-30

Locations

29 sites across 4 countries: United States, Australia, South Korea, Spain

Regulatory

• FDA-regulated drug study