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

ID#: NCT05536141

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: October 26, 2022

End Date: January 01, 2026

Contact Information:
Medical Director
1-888-44-ARCUS
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) during the dose escalation stage; and - AB521 monotherapy and AB521 in combination with cabozantinib in participants with ccRCC in the dose expansion stage
Eligibility: 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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