Clinical trial NCT05536141: A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Clear Cell Renal Cell Carcinoma
Solid Tumors
Keywords: Clear Cell Renal Cell Carcinoma
Solid Tumor Malignancies
AB521
Casdatifan
Kidney Cancer
Zimberelimab
AB122
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 in participants with ccRCC in the dose expansion stage


Eligibility 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
* 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.

Primary outcomes:
measure: Number of participants with dose limiting toxicities (DLTs)
timeFrame: Up to 4 months
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 4 months
Secondary outcomes:
measure: Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to 4 months
measure: Plasma concentration of casdatifan
timeFrame: Up to 4 months
measure: Area under the plasma concentration time curve (AUC) of casdatifan
timeFrame: Up to 4 months
measure: Maximum Observed Plasma Concentration (Cmax) of casdatifan
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: Santa Monica
country: United States
facility: UCLA
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Louisville
country: United States
facility: University of Louisville Brown Cancer Center
state: Kentucky
city: New Orleans
country: United States
facility: Oschner Health
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Omaha
country: United States
facility: Nebraska Cancer Specialists - Oncology Hematology West PC
state: Nebraska
city: New York
country: United States
facility: Tisch Cancer Institute, Icahn Mount Sinai Hospital
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Clinical
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC
state: Texas
city: Spokane
country: United States
facility: Medical Oncology Associates Summit Cancer Centers
state: Washington
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
city: Melbourne
country: Australia
facility: Box Hill Hospital
city: Sydney
country: Australia
facility: Ashford Cancer Centre Research/ICON
city: Sydney
country: Australia
facility: Macquarie University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Arcus Biosciences
name: Medical Director
role: STUDY_DIRECTOR
References: