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Phase 1 Study of AB521 for Renal Cell Carcinoma and Other Solid Tumors

This study is testing the safety of a drug called casdatifan, both on its own and in combination with other approved cancer medicines: cabozantinib, zimberelimab, and ipilimumab. It's for people with advanced solid tumors or clear cell renal cell carcinoma (a type of kidney cancer). To join, you must have at least one measurable tumor and a good general health status (ECOG performance status score of ≤ 1). The main goal is to see how safe these treatments are and what side effects might occur. This study aims to enroll 362 participants.

Study design
This is a Phase 1 interventional study, meaning it's an early-stage trial focused on safety. It plans to enroll 362 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for dose-limiting toxicities and adverse events for up to 4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05536141

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Arcus Biosciences, Inc.
~362 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:casdatifanCabozantinibZimberelimabIpilimumab

At a glance

Recruiting sites
24 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with dose limiting toxicities (DLTs)
Measured over Up to 4 months
+1 more outcome measured

Conditions

Clear Cell Renal Cell Carcinoma
Solid Tumors

Explore related trials

Clear Cell Renal Cell CarcinomaSolid Neoplasm

NCT05536141

Where you'd take part

This study runs at 25 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Birmingham, Alabamano site contact published

    Recruiting

  • Research Site

    San Diego, Californiano site contact published

    Recruiting

  • Research Site

    Santa Monica, Californiano site contact published

    Recruiting

  • Research Site

    Miami, Floridano site contact published

    Recruiting

  • Research Site

    Atlanta, Georgiano site contact published

    Recruiting

  • Research Site

    Louisville, Kentuckyno site contact published

    Recruiting

  • Research Site

    New Orleans, Louisianano site contact published

    Recruiting

  • Research Site

    Baltimore, Marylandno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Arcus Biosciences

Who to contact

Medical Director
[email protected]
+1-510-462-3330
Email the study team

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Eligibility criteria

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
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

What this trial measures

  • Number of participants with dose limiting toxicities (DLTs)Up to 4 months
  • Number of participants with adverse events (AEs)Up to 4 months