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

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

Conditions

Clear Cell Renal Cell Carcinoma, Solid Tumors

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Clear Cell Renal Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Santa Monica

UCLA, Santa Monica, California, United States, 90404

Miami

University of Miami, Miami, Florida, United States, 33136

Louisville

University of Louisville Brown Cancer Center, Louisville, Kentucky, United States, 40202

New Orleans

Oschner Health, New Orleans, Louisiana, United States, 70121

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Barbara Ann Karmanos Cancer Center, Detroit, Michigan, United States, 48201

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

Omaha

Nebraska Cancer Specialists - Oncology Hematology West PC, Omaha, Nebraska, United States, 68124

New York

Tisch Cancer Institute, Icahn Mount Sinai Hospital, New York, New York, United States, 10029

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Histologically confirmed ccRCC
  • * Creatinine clearance ≥ 40 mL/min
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arcus Biosciences, Inc.,

Medical Director, STUDY_DIRECTOR, Arcus Biosciences

Study Record Dates

2027-07