Actively Recruiting
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
Led by Arcus Biosciences, Inc. · Updated on 2026-05-01
362
Participants Needed
25
Research Sites
331 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.
CONDITIONS
Official Title
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one measurable lesion per RECIST guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status score of 64 1
- For dose escalation: any pathologically confirmed solid tumor type with no other treatment options
- Creatinine clearance 64 40 mL/min
- For dose expansion: histologically confirmed clear cell renal cell carcinoma
- Creatinine clearance 64 40 mL/min
You will not qualify if you...
- Use of live vaccines against infectious diseases within 4 weeks before starting treatment
- Any significant cardiac, respiratory, medical, or psychiatric condition interfering with study participation or safety
- History of trauma or major surgery within 28 days before first dose
- Prior treatment with hypoxia inducible factor (HIF)-2b1 inhibitors for all expansion cohorts
- Prior treatment with cabozantinib for casdatifan + cabozantinib group
- Prior systemic cancer treatment for casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab groups
- Known psychiatric or substance abuse disorders interfering with trial cooperation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Research Site
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Research Site
San Diego, California, United States, 92093
Actively Recruiting
3
Research Site
Santa Monica, California, United States, 90404
Actively Recruiting
4
Research Site
Miami, Florida, United States, 33136
Actively Recruiting
5
Research Site
Atlanta, Georgia, United States, 30322-1013
Actively Recruiting
6
Research Site
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Research Site
New Orleans, Louisiana, United States, 70121
Actively Recruiting
8
Research Site
Baltimore, Maryland, United States, 21287
Actively Recruiting
9
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Research Site
Detroit, Michigan, United States, 48201
Actively Recruiting
11
Research Site
Detroit, Michigan, United States, 48202
Actively Recruiting
12
Research Site
Omaha, Nebraska, United States, 68124
Actively Recruiting
13
Research Site
New York, New York, United States, 10029
Actively Recruiting
14
Research Site
New York, New York, United States, 10065
Actively Recruiting
15
Research Site
Cleveland, Ohio, United States, 44106
Actively Recruiting
16
Research Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
17
Research Site
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
18
Research Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
19
Research Site
Nashville, Tennessee, United States, 37240
Actively Recruiting
20
Research Site
San Antonio, Texas, United States, 78229
Actively Recruiting
21
Research Site
Camperdown, Australia
Not Yet Recruiting
22
Research Site
Melbourne, Australia
Not Yet Recruiting
23
Research Site
Sydney, Australia
Actively Recruiting
24
Research Site
Seoul, South Korea
Actively Recruiting
25
Research Site
Barcelona, Spain
Not Yet Recruiting
Research Team
M
Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
15
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