Vanderbilt Clinical Trials

A Phase 1 Study of AB521 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).

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, must have received prior treatment in the metastatic setting (either individually or in combination) with an anti-programmed cell death protein 1 (anti-PD-1) therapy and a tyrosine kinase inhibitor (TKI), and no prior treatment with a hypoxia inducible factor (HIF)-2 alpha (α)-targeting 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. - Underlying medical conditions that, in the investigator's judgment, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalizations with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs. - History of trauma or major surgery within 28 days prior to the first dose of investigational product. - For monotherapy dose expansion: prior treatment with an HIF-2α inhibitor. - 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	Drug: AB521 Administered as specified in the treatment arm
Experimental Dose Escalation Cohort 2	Participants will receive AB521 orally once daily	Drug: AB521 Administered as specified in the treatment arm
Experimental Dose Escalation Cohort 3	Participants will receive AB521 orally twice daily	Drug: AB521 Administered as specified in the treatment arm
Experimental Dose Escalation Cohort 4	Participants will receive AB521 orally	Drug: AB521 Administered as specified in the treatment arm
Experimental Dose Expansion Cohort 1	Participants will receive AB521 orally	Drug: AB521 Administered as specified in the treatment arm
Experimental Dose Expansion Cohort 2	Participants will receive AB521 orally	Drug: AB521 Administered as specified in the treatment arm
Experimental Dose Expansion Cohort 3	Participants will receive AB521 orally	Drug: AB521 Administered as specified in the treatment arm

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
ClinicalTrials@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.