A Phase I, 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
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Study Summary
To evaluate AB-521 in patients with clear-cell renal cell carcinoma To investigate the safety, tolerability, and pharmacology of AB521 monotherapy in patients with solid tumors and evaluate the clinical activity of AB521 in previously treated patients with ccRCC. To evaluating the safety, tolerability, pharmacokinetics, and preliminary clinical activity of cas monotherapy in pts with advanced solid tumor malignancies (escalation) and as monotherapy in pts with ccRCC (expansion). Response assessed by investigator per RECIST v1.1. To investigate the safety and efficacy of casdatifan in combination with the anti–vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) cabozantinib in previously treated patients with ccRCC in an expansion cohort (casdatifan + cabozantinib).
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.
- 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
- 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)-2 inhibitor. For the AB521 + 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.
Clinical Study Information for Healthcare Providers
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