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

Prior treatment

• 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.

Other illness

• 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.

• 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