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Evaluating AB521 for kidney cancer 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

Phase 1 Interventional Arcus Biosciences, Inc. · NCT05536141

This study is testing a new treatment called casdatifan, alone and with other medications, to see if it helps people with advanced kidney cancer and other solid tumors feel better.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment362 (estimated)
Ages18 Years and up
SexAll
SponsorArcus Biosciences, Inc. Industry-sponsored
Drugs / interventionszimberelimab, ipilimumab, cabozantinib
Locations25 sites (Birmingham, Alabama and 24 other locations)
Trial IDNCT05536141 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of casdatifan, both as a standalone treatment and in combination with cabozantinib or zimberelimab, for patients with advanced solid tumors, particularly clear cell renal cell carcinoma (ccRCC). The trial consists of a dose escalation phase to determine the optimal dosage and a dose expansion phase focusing on ccRCC patients. Participants must have measurable lesions and meet specific health criteria to be eligible for the study.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced clear cell renal cell carcinoma or other solid tumors who have limited treatment options.

Not a fit: Patients with significant comorbidities or those who have had recent major surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced kidney cancer and other solid tumors.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating renal cell carcinoma, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Must have at least one measurable lesion per RECIST guidance
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
* Disease-specific criteria for dose escalation:

  * Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
  * Creatinine clearance ≥ 40 mL/min

Disease-specific criteria for dose-expansion:

* Histologically confirmed ccRCC
* Creatinine clearance ≥ 40 mL/min

Key Exclusion Criteria:

* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous
* History of trauma or major surgery within 28 days prior to the first dose of investigational product
* For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Birmingham, Alabama and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Clear Cell Renal Cell CarcinomaSolid TumorsAB521CasdatifanKidney CancerZimberelimabAB122Hif2a
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.