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

NCT05536141 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2026-05-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

casdatifan

Administered as specified in the treatment arm

DRUG

Cabozantinib

Administered as specified in the treatment arm

DRUG

Zimberelimab

Administered as specified in the treatment arm

DRUG

Ipilimumab

Administered as specified in the treatment arm

Sponsors & Collaborators

  • Arcus Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Arcus Biosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2029-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05536141 on ClinicalTrials.gov