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Clinical Trials in Spain / NCT05536141
Recruiting Phase 1

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

NCT05536141 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2022-10-26
Last updated
2026-08-31

Condition(s) studied

Clear Cell Renal Cell CarcinomaSolid Tumors

Investigational drug(s) / intervention(s)

casdatifan →Cabozantinib →Zimberelimab →Ipilimumab →

casdatifan: Administered as specified in the treatment arm

Cabozantinib: Administered as specified in the treatment arm

Zimberelimab: Administered as specified in the treatment arm

Ipilimumab: Administered as specified in the treatment arm

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Research Site Birmingham Alabama Recruiting
Research Site San Diego California Recruiting
Research Site Santa Monica California Recruiting
Research Site Miami Florida Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Louisville Kentucky Recruiting
Research Site New Orleans Louisiana Recruiting
Research Site Baltimore Maryland Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Detroit Michigan Recruiting
Research Site Detroit Michigan Recruiting
Research Site Omaha Nebraska Recruiting
Research Site New York New York Recruiting
Research Site New York New York Recruiting
Research Site Cleveland Ohio Recruiting
Research Site Cleveland Ohio Recruiting
Research Site Pittsburgh Pennsylvania Recruiting
Research Site Nashville Tennessee Recruiting
Research Site Nashville Tennessee Recruiting
Research Site San Antonio Texas Recruiting
Research Site Camperdown Australia Not Yet Recruiting
Research Site Melbourne Australia Recruiting
Research Site Sydney Australia Recruiting
Research Site Seoul South Korea Recruiting
Research Site Barcelona Spain Recruiting

On this site

📄 Cabometyx (cabozantinib) drug profile →

More Arcus Biosciences, Inc. trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05536141 on ClinicalTrials.gov ↗ ← All trials in Spain