A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors (ARC-20)
- Conditions
- Clear Cell Renal Cell CarcinomaSolid Tumors
- Interventions
- Registration Number
- 2024-519142-70-00
- Lead Sponsor
- Arcus Biosciences Inc.
- Brief 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 in participants with ccRCC in the dose expansion stage
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 7
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Cohort 1 casdatifan Participants will receive casdatifan orally once daily Dose Escalation Cohort 2 casdatifan Participants will receive casdatifan orally once daily Dose Escalation Cohort 3 casdatifan Participants will receive casdatifan orally twice daily Dose Escalation Cohort 4 casdatifan Participants will receive casdatifan orally once daily Dose Escalation Cohort 5 casdatifan Participants will receive casdatifan orally once daily Dose Expansion Cohort 1 casdatifan Participants will receive casdatifan orally Dose Expansion Cohort 2 casdatifan Participants will receive casdatifan orally Dose Expansion Cohort 3 casdatifan Participants will receive casdatifan orally Dose Expansion Cohort 4 casdatifan Participants will receive casdatifan orally with with cabozantinib orally Dose Expansion Cohort 4 Cabozantinib Participants will receive casdatifan orally with with cabozantinib orally Dose Expansion Cohort 5 casdatifan Participants will receive casdatifan orally Dose Expansion Cohort 6 casdatifan Participants will receive casdatifan orally Dose Expansion Cohort 7 casdatifan Participants will receive casdatifan orally with zimberelimab infusion Dose Expansion Cohort 7 Zimberelimab Participants will receive casdatifan orally with zimberelimab infusion Dose Expansion Cohort 8 casdatifan Participants will receive casdatifan orally
- Primary Outcome Measures
Name Time Method Number of participants with dose limiting toxicities (DLTs) Up to 4 months Number of participants with adverse events (AEs) Up to 4 months
- Secondary Outcome Measures
Name Time Method Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to 4 months Plasma concentration of casdatifan Up to 4 months Area under the plasma concentration time curve (AUC) of casdatifan Up to 4 months Maximum Observed Plasma Concentration (Cmax) of casdatifan Up to 4 months
Trial Locations
- Locations (23)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
UCLA
🇺🇸Santa Monica, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Louisville Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Oschner Health
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
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