Actively Recruiting
A Phase 1, Open-label, Dose Escalation and Dose Expansion Study to Investigate Safety and Pharmacokinetics of AB521 Monotherapy and Combination Therapies in Clear Cell Renal Cell Carcinoma and Other Solid Tumors
Led by Arcus Biosciences, Inc. · Updated on 2026-06-01
362
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of casdatifan alone and in combination with other drugs in adults with advanced solid tumor cancers, including clear cell renal cell carcinoma (ccRCC). This phase 1 study focuses on dose escalation and dose expansion stages to understand how well patients tolerate casdatifan by itself and when combined with cabozantinib, zimberelimab, or ipilimumab. The study aims to gather important safety data and pharmacokinetic profiles in participants with these cancers. Participants will receive casdatifan orally, mostly once daily, though dosing frequency may vary. In the dose expansion phase, some participants will receive casdatifan combined with cabozantinib orally or with zimberelimab and/or ipilimumab administered by infusion. The study includes multiple experimental cohorts with different dosing schedules to assess these therapies alone or in combination. During the study, participants will be monitored for dose limiting toxicities and adverse events over up to four months. Researchers will measure drug levels in plasma and evaluate tumor response using standard criteria. This open-label study involves detailed safety and tolerability assessments to collect information on how participants respond to the treatments. The total participation duration varies based on treatment and follow-up schedules.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Must have at least one measurable lesion per RECIST guidance
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- For dose escalation: any solid tumor with no other treatment options
- Creatinine clearance of 40 mL/min or higher
- For dose expansion: histologically confirmed clear cell renal cell carcinoma
- Creatinine clearance of 40 mL/min or higher
You will not qualify if you...
- Use of any live vaccines within 4 weeks prior to starting study treatment
- Clinically significant cardiac, respiratory, medical, or psychiatric conditions that interfere with study participation or treatment safety
- History of trauma or major surgery within 28 days before starting treatment
- Prior treatment with hypoxia inducible factor (HIF)-2α inhibitors in expansion cohorts
- Prior cabozantinib treatment in the casdatifan plus cabozantinib group
- Prior systemic treatment when cancer is present in casdatifan plus zimberelimab and ipilimumab groups
- Known psychiatric or substance abuse disorders that affect cooperation with the trial requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months
Participants receive oral casdatifan alone or in combination with other drugs as specified by their treatment group.
Regular visits during treatment for monitoring safety and response
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
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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