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RecruitingLast updated: 30 April 2026

ARC-20: Targeted therapy alone or in combination with medicines in people with clear cell renal cell carcinoma and other solid cancersA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

ARC-20

Clinical summary

Summary

This trial has two stages.

Dose Escalation stage
The purpose of this part is to see how safe and tolerable casdatifan (also called AB521) is when given by itself, in people with advanced solid cancers and clear cell renal cell carcinoma (ccRCC). Casdatifan will be given as an oral medicine.

Dose Expansion stage
This part will evaluate casdatifan by itself, as well as casdatifan in combination with other medicines (this could include cabozantinib, ximberelimab, zimberelimab and ipilimumab) in people with ccRCC.

 

Conditions

This trial is treating people with clear cell renal cell carcinoma (ccRCC) and other advanced solid cancers

Eligibility

Inclusion

  • 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

Exclusion

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Arcus Biosciences, Inc.

Scientific 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

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