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

Summary

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.

Eligibility

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.

Conditions3

Interventions4

Locations20 sites

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