Kidney Cancer Clinical Trial
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 AB521 when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC).
Eligibility Criteria
Key Inclusion Criteria:
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 AB521 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 AB521 + 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
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 AB521 + 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.
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There are 15 Locations for this study
Santa Monica California, 90404, United States
Miami Florida, 33136, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70121, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Omaha Nebraska, 68124, United States
New York New York, 10129, United States
Cleveland Ohio, 44195, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37240, United States
San Antonio Texas, 78229, United States
Seoul , 13620, Korea, Republic of
Seoul , 6351, Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
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