RECRUITING

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

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Conditions

Clear Cell Renal Cell CarcinomaSolid TumorsSolid Tumor MalignanciesAB521CasdatifanKidney Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Quick Facts

Study Start:2022-10-26
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05536141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have at least one measurable lesion per RECIST guidance
  2. * Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
  3. * Disease-specific criteria for dose escalation:
  4. * Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
  5. * Creatinine clearance ≥ 40 mL/min
  6. * Histologically confirmed ccRCC
  7. * Creatinine clearance ≥ 40 mL/min
  1. * Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
  2. * 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
  3. * History of trauma or major surgery within 28 days prior to the first dose of investigational product
  4. * 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
  5. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Contacts and Locations

Study Contact

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

Principal Investigator

Medical Director
STUDY_DIRECTOR
Arcus Biosciences

Study Locations (Sites)

UCLA
Santa Monica, California, 90404
United States
University of Miami
Miami, Florida, 33136
United States
University of Louisville Brown Cancer Center
Louisville, Kentucky, 40202
United States
Oschner Health
New Orleans, Louisiana, 70121
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Nebraska Cancer Specialists - Oncology Hematology West PC
Omaha, Nebraska, 68124
United States
Tisch Cancer Institute, Icahn Mount Sinai Hospital
New York, New York, 10029
United States
Weill Medical College of Cornell University
New York, New York, 10065
United States
University Hospitals Cleveland Clinical
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Sarah Cannon
Nashville, Tennessee, 37203
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37240
United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Arcus Biosciences, Inc.

  • Medical Director, STUDY_DIRECTOR, Arcus Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-26
Study Completion Date2027-07

Study Record Updates

Study Start Date2022-10-26
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Clear Cell Renal Cell Carcinoma
  • Solid Tumor Malignancies
  • AB521
  • Casdatifan
  • Kidney Cancer

Additional Relevant MeSH Terms

  • Clear Cell Renal Cell Carcinoma
  • Solid Tumors