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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Arcus Biosciences, Inc. · Participants: 362 · Started: Oct 26, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05536141

Locations in the U.S.

AlabamaResearch Site, Birmingham
CaliforniaResearch Site, San Diego
Research Site, Santa Monica
FloridaResearch Site, Miami
GeorgiaResearch Site, Atlanta
KentuckyResearch Site, Louisville
LouisianaResearch Site, New Orleans
MarylandResearch Site, Baltimore
MassachusettsResearch Site, Boston
MichiganResearch Site, Detroit
Research Site, Detroit
NebraskaResearch Site, Omaha
New YorkResearch Site, New York
Research Site, New York
OhioResearch Site, Cleveland
Research Site, Cleveland
PennsylvaniaResearch Site, Pittsburgh
TennesseeResearch Site, Nashville
Research Site, Nashville
TexasResearch Site, San Antonio

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.