Actively Recruiting
A Study of ASP1002 in Adults for Treatment of Solid Tumors
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-03-18
210
Participants Needed
15
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main aims of this study are: * To check the safety of ASP1002 in people with certain solid tumors. * To check if the people can tolerate ASP1002. * To find a suitable dose of ASP1002. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP1002. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP1002 to use in Part 2 of the study. In Part 2, other different small groups of people will receive doses of ASP1002 that worked the best in Part 1. People in this study will be adults with metastatic or locally advanced solid tumors with high levels of a protein called claudin 4. The people's cancer will have either spread to other parts of the body (metastatic) or spread to tissue close by (locally advanced). They will have been previously treated with available standard therapies or refused to receive those treatments. In both parts of the study, ASP1002 (the study treatment) will be given to people slowly through a tube into a vein. This is called an infusion. This will happen every week, every other week, or every 3 weeks, in treatment cycles. Treatment cycles may be 21 days or 28 days long. People in this study will continue treatment for up to 2 years until: they have medical problems that prevent them from continuing treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; they do not come back for treatment. During the study, people will visit the clinic several times for a health check. This includes standard safety checks and reporting any medical problems. Every few weeks, the study doctors will check if each person's cancer has stayed the same or got worse. This will be done by scans (CT or MRI scans). Tumor samples will be taken during the study and people will have the option of giving a tumor sample after treatment has finished. People will visit the clinic within 7 days after stopping treatment for a health check. Then, they may visit the clinic at 1 month and 3 months after stopping treatment for further health checks. People will have follow-up health checks for up to 1 year after their last dose of ASP1002.
CONDITIONS
Official Title
A Study of ASP1002 in Adults for Treatment of Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with locally advanced (unresectable) or metastatic solid tumors confirmed by pathology or biopsy
- For dose escalation: specific tumor types including certain non-small cell lung cancers, urothelial carcinoma, colorectal cancer, prostate adenocarcinoma, epithelial ovarian cancer, and triple-negative breast cancer
- For dose expansion: similar tumor types or tumors with confirmed response during dose escalation
- Female participants must not be pregnant and either not of childbearing potential or agree to contraception during and 90 days after treatment
- Participants must have progressed on, be intolerant of, refused, or have no standard approved therapies
- Participants must have accessible tumor tissue less than 6 months old or undergo biopsy if safe
- Participants must have at least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Radiotherapy completed at least 2 weeks before study treatment
- Predicted life expectancy of at least 12 weeks
- Adequate organ function before starting treatment
- Agreement to avoid certain reproductive activities and donations during and 90 days after treatment
- Agreement not to participate in another interventional study while receiving study treatment
You will not qualify if you...
- Weighing less than 40 kg
- Ongoing significant toxicity (grade 2 or higher) from prior cancer treatments
- Symptomatic or uncontrolled central nervous system metastases
- Active autoimmune diseases requiring systemic treatment
- Recent heart attack, unstable angina, or uncontrolled cardiac illness
- Corrected QT interval over 470 ms on ECG within 7 days before treatment
- Left ventricular ejection fraction below 45%
- Known HIV infection unless stable with no recent AIDS-defining infections
- Positive hepatitis A, B, or C tests unless viral RNA is undetectable
- History of drug-induced pneumonitis, interstitial lung disease, or non-infectious pneumonitis requiring high-dose steroids
- Uncontrolled infection, substance abuse, psychiatric illness, or social situations interfering with study compliance
- Prior allogeneic bone marrow or solid organ transplant
- Major surgery not fully recovered from within 28 days before treatment
- Recent positive COVID-19 antigen test within 10 days unless asymptomatic after 10 days
- Recent investigational or immunotherapy within 21 days or 5 half-lives before treatment
- Requirement for systemic steroids or immunosuppressive therapy within 14 days prior to treatment, except low-dose corticosteroids as specified
- Prior discontinuation from immunomodulatory therapy due to severe toxicity
- Expected need for other cancer therapies during study treatment
- Other malignancies requiring active therapy
- Prior anti-CD137 therapy
- Recent live vaccine within 28 days before treatment
- Known hypersensitivity to ASP1002 or its components
- Any condition making participation unsuitable
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Yale University Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
Plainville, Connecticut, United States, 06062
Actively Recruiting
3
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
4
University of Iowa Hospitals
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
7
HealthPartners Cancer Research Center
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
8
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
9
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
10
Prisma Health-Upstate Cancer Institute
Greenville, South Carolina, United States, 29605
Completed
11
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Completed
12
University of Texas Southwestern
Dallas, Texas, United States, 75235
Completed
13
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75251
Actively Recruiting
14
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
15
Swedish Cancer Institute
Edmonds, Washington, United States, 21632
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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