Trial Title:
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
NCT ID:
NCT05536141
Condition:
Clear Cell Renal Cell Carcinoma
Solid Tumors
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
Clear Cell Renal Cell Carcinoma
Solid Tumor Malignancies
Pharmacokinetics
Pharmacodynamics
AB521
Casdatifan
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
casdatifan
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Escalation Cohort 1
Arm group label:
Dose Escalation Cohort 2
Arm group label:
Dose Escalation Cohort 3
Arm group label:
Dose Escalation Cohort 4
Arm group label:
Dose Escalation Cohort 5
Arm group label:
Dose Expansion Cohort 1
Arm group label:
Dose Expansion Cohort 2
Arm group label:
Dose Expansion Cohort 3
Arm group label:
Dose Expansion Cohort 4
Other name:
AB521
Intervention type:
Drug
Intervention name:
Cabozantinib
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Expansion Cohort 4
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 in
participants with ccRCC in the dose expansion stage
Criteria for eligibility:
Criteria:
Key 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
- For casdatifan monotherapy cohorts: participants must have received prior
treatment in the metastatic setting with an anti-PD-1/PD-L1 therapy and a
vascular endothelial growth factor receptor-targeting tyrosine kinase inhibitor
(VEGFR-targeting TKI), (either individually or in combination)
- For casdatifan + cabozantinib combination therapy: participants must have
received prior treatment for locally advanced or metastatic disease with
anti-PD-1/PD-L1 therapy in an immediately preceding line of therapy
- Must have at least one measurable lesion per RECIST guidance
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Louisville Brown Cancer Center
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Facility:
Name:
Oschner Health
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Barbara Ann Karmanos Cancer Center
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Nebraska Cancer Specialists - Oncology Hematology West PC
Address:
City:
Omaha
Zip:
68124
Country:
United States
Status:
Recruiting
Facility:
Name:
Tisch Cancer Institute, Mount Sinai Hospital
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospitals Cleveland Clinical
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Vanderbilt-Ingram Cancer Center
Address:
City:
Nashville
Zip:
37240
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics, LLC
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
ICON
Address:
City:
Adelaide
Country:
Australia
Status:
Recruiting
Facility:
Name:
Box Hill Hospital
Address:
City:
Box Hill
Country:
Australia
Status:
Recruiting
Facility:
Name:
Macquarie University Hospital
Address:
City:
Melbourne
Country:
Australia
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Start date:
October 26, 2022
Completion date:
January 2026
Lead sponsor:
Agency:
Arcus Biosciences, Inc.
Agency class:
Industry
Source:
Arcus Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05536141
https://trials.arcusbio.com/study/?id=ARC-20
