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

Open to people ages 18 years and up

• Disease-specific criteria for dose escalation:
• Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
• Disease-specific criteria for dose-expansion:
  • Histologically confirmed ccRCC
  • For casdatifan monotherapy cohorts: participants must have received prior treatment in the metastatic setting with an anti-PD-1/PD-L1 therapy and a vascular endothelial growth factor receptor-targeting tyrosine kinase inhibitor (VEGFR-targeting TKI), (either individually or in combination)
  • For casdatifan + cabozantinib combination therapy: participants must have received prior treatment for locally advanced or metastatic disease with anti-PD-1/PD-L1 therapy in an immediately preceding line of therapy
• Must have at least one measurable lesion per RECIST guidance
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1

• 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.