A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
Purpose
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
Conditions
- Clear Cell Renal Cell Carcinoma
- Solid Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation Cohort 1 |
Participants will receive AB521 orally once daily |
|
|
Experimental Dose Escalation Cohort 2 |
Participants will receive AB521 orally once daily |
|
|
Experimental Dose Escalation Cohort 3 |
Participants will receive AB521 orally twice daily |
|
|
Experimental Dose Escalation Cohort 4 |
Participants will receive AB521 orally |
|
|
Experimental Dose Escalation Cohort 5 |
Participants will receive AB521 orally |
|
|
Experimental Dose Expansion Cohort 1 |
Participants will receive AB521 orally |
|
|
Experimental Dose Expansion Cohort 2 |
Participants will receive AB521 orally |
|
|
Experimental Dose Expansion Cohort 3 |
Participants will receive AB521 orally |
|
|
Experimental Dose Expansion Cohort 4 |
Participants will receive AB521 orally with Cabozantinib |
|
Recruiting Locations
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37240
Nashville, Tennessee 37240
More Details
- Status
- Recruiting
- Sponsor
- Arcus Biosciences, Inc.