An official website of the United States government
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
Trial Status: active
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 in participants with ccRCC in the dose expansion stage
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
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05536141.
