Clinical Trial: NCT05536141
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
Status:
RECRUITINGPhase:
Phase 1| Lead Sponsor: | Arcus Biosciences, Inc. |
| Information Provided By: | Arcus Biosciences, Inc. |
| Last Update Posted: | 2026-10-05 |
Study Overview
Brief 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.
Official Title
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
Conditions
Clear Cell Renal Cell Carcinoma, Solid Tumors
Intervention / Treatment
- Drug: casdatifan
- Drug: Cabozantinib
- Drug: Zimberelimab
- Drug: Ipilimumab
Other Study ID Numbers
- ARC-20
- 2024-519142-70-00
Start Date (Actual)
2022-10-26
Primary Completion Date (Estimated)
2029-03
Study Completion Date (Estimated)
2029-03
Enrollment (Estimated)
362
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Arcus Biosciences, Inc. |
| Information Provided By: | Arcus Biosciences, Inc. |
| Last Update Posted: | 2026-10-05 |
Study Overview
Brief 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.
Official Title
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
Conditions
Clear Cell Renal Cell Carcinoma, Solid Tumors
Intervention / Treatment
- Drug: casdatifan
- Drug: Cabozantinib
- Drug: Zimberelimab
- Drug: Ipilimumab
Other Study ID Numbers
- ARC-20
- 2024-519142-70-00
Start Date (Actual)
2022-10-26
Primary Completion Date (Estimated)
2029-03
Study Completion Date (Estimated)
2029-03
Enrollment (Estimated)
362
Study Type
Interventional
Phase
Phase 1