Vanderbilt Clinical Trials

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: - 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

Conditions

Clear Cell Renal Cell Carcinoma
Solid Tumors

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

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 - 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 casdatifan orally once daily	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521
Experimental Dose Escalation Cohort 2	Participants will receive casdatifan orally once daily	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521
Experimental Dose Escalation Cohort 3	Participants will receive casdatifan orally twice daily	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521
Experimental Dose Escalation Cohort 4	Participants will receive casdatifan orally once daily	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521
Experimental Dose Escalation Cohort 5	Participants will receive casdatifan orally once daily	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521
Experimental Dose Expansion Cohort 1	Participants will receive casdatifan orally	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521
Experimental Dose Expansion Cohort 2	Participants will receive casdatifan orally	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521
Experimental Dose Expansion Cohort 3	Participants will receive casdatifan orally	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521
Experimental Dose Expansion Cohort 4	Participants will receive casdatifan orally with with cabozantinib orally	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521 Drug: Cabozantinib Administered as specified in the treatment arm
Experimental Dose Expansion Cohort 5	Participants will receive casdatifan orally	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521
Experimental Dose Expansion Cohort 6	Participants will receive casdatifan orally	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521
Experimental Dose Expansion Cohort 7	Participants will receive casdatifan orally with zimberelimab infusion	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521 Drug: Zimberelimab Administered as specified in the treatment arm
Experimental Dose Expansion Cohort 8	Participants will receive casdatifan orally	Drug: casdatifan Administered as specified in the treatment arm Other names: AB521

Recruiting Locations

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37240

More Details

Status: Recruiting
Sponsor: Arcus Biosciences, Inc.

Study Contact

Medical Director
+1-510-462-3330
ClinicalTrialInquiry@arcusbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.