Clear Cell Renal Cell Carcinoma, Solid Tumors
Conditions
Keywords
Clear Cell Renal Cell Carcinoma, AB521, Casdatifan, Kidney Cancer, Zimberelimab, AB122, Hif2a
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 or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.
Interventions
DRUGcasdatifan
Administered as specified in the treatment arm
DRUGCabozantinib
Administered as specified in the treatment arm
DRUGZimberelimab
Administered as specified in the treatment arm
DRUGIpilimumab
Administered as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with dose limiting toxicities (DLTs) | Up to 4 months |
| Number of participants with adverse events (AEs) | Up to 4 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia, South Korea, Spain, United States
Contacts
CONTACTMedical Director
STUDY_DIRECTORMedical Director
Arcus Biosciences
Outcome results
None listed