Evaluating AB521 for kidney cancer and other solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and tolerability of casdatifan, both as a standalone treatment and in combination with cabozantinib or zimberelimab, for patients with advanced solid tumors, particularly clear cell renal cell carcinoma (ccRCC). The trial consists of a dose escalation phase to determine the optimal dosage and a dose expansion phase focusing on ccRCC patients. Participants must have measurable lesions and meet specific health criteria to be eligible for the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Birmingham, Alabama, United States Recruiting
• Research Site
  San Diego, California, United States Recruiting
• Research Site
  Santa Monica, California, United States Recruiting
• Research Site
  Miami, Florida, United States Recruiting
• Research Site
  Atlanta, Georgia, United States Recruiting
• Research Site
  Louisville, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Medical Director
• Email: ClinicalTrialInquiry@arcusbio.com
• Phone: +1-510-462-3330

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cadonilimab and Lenvatinib in advanced kidney cancer

  This study tests whether Cadonilimab plus Lenvatinib can help adults with unresectable, advanced renal cell carcinoma, especially clear cell type, after prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Panjiayuan Nanli · NCT07909265

• BA1203 in advanced solid tumors: safety and early signs of activity

  This early-phase trial tests BA1203 in adults with advanced solid tumors to see if it is safe, tolerable, how the drug behaves in the body, and whether it shows any early signs of effectiveness.

  Recruiting Phase 1 Shandong Boan Biotechnology Co., Ltd · Beijing · NCT07876609

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

• CAIX-targeted PET/CT imaging in solid tumors

  Researchers are testing a CAIX-targeted PET/CT imaging agent to see if it detects and reflects CAIX levels in solid tumors like clear cell renal cell carcinoma, NSCLC, and breast cancer.

  Recruiting Zhongnan Hospital · Wuhan, Hubei · NCT07833085

• REC-7735 for PIK3CA-H1047R-mutant solid tumors

  This study tests REC-7735 in people with unresectable, locally advanced, or metastatic solid tumors that carry the PIK3CA-H1047R mutation.

  Recruiting at 3 sites Phase 1/2 Recursion Pharmaceuticals Inc. · Grand Rapids, Michigan and 2 other locations · NCT07819136

• Preferences of physicians and patients for cell therapies in advanced solid tumors

  This study tests how doctors and patients weigh the benefits, risks, and burdens of CAR-T, TIL, TCR-T, and NK cell therapies in advanced solid cancers.

  Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT07813000

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.