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NCT Number: NCT05536141

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

casdatifan

Drug

Administered as specified in the treatment arm

Other names: AB521

Cabozantinib

Drug

Administered as specified in the treatment arm

Zimberelimab

Drug

Administered as specified in the treatment arm

Other names: AB122

Ipilimumab

Drug

Administered as specified in the treatment arm

Primary outcomes

  1. Number of participants with dose limiting toxicities (DLTs)

    Time frame: Up to 4 months

  2. Number of participants with adverse events (AEs)

    Time frame: Up to 4 months

Secondary outcomes

  1. Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Up to 4 months

  2. Plasma concentration of casdatifan

    Time frame: Up to 4 months

  3. Area under the plasma concentration time curve (AUC) of casdatifan

    Time frame: Up to 4 months

  4. Maximum Observed Plasma Concentration (Cmax) of casdatifan

    Time frame: Up to 4 months

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director

CONTACT

[email protected]

+1-510-462-3330

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Registry information

Official study 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

Acronym: ARC-20

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Sep 10, 2022
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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