Actively Recruiting
A Phase 1 Study of ASP1002 in Participants With Metastatic or Locally Advanced Solid Tumors
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-03-18
210
Participants Needed
15
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ASP1002, an investigational drug, for adults with metastatic or locally advanced solid tumors that have high levels of a protein called claudin 4. The study aims to check the safety and tolerability of ASP1002 and to find suitable doses. Participants have cancers that have spread or are locally advanced and have previously been treated with standard therapies or have refused them. The study has two parts. In Part 1, small groups receive ascending doses of ASP1002 through weekly, biweekly, or triweekly intravenous infusions in treatment cycles lasting 21 or 28 days. Researchers record medical problems to determine appropriate doses. In Part 2, other groups receive the best doses found in Part 1. Treatment continues for up to two years unless medical issues, cancer progression, new treatments, participant choice, or missed visits occur. Participants will visit the clinic multiple times for health checks, including safety monitoring and reporting medical issues. Tumor status will be assessed regularly with CT or MRI scans. Tumor tissue samples will be collected during and optionally after treatment. After stopping treatment, participants have follow-up visits within 7 days, then at 1 and 3 months, with health monitoring continuing for up to a year after the last dose.
CONDITIONS
Brief 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 or metastatic solid tumors confirmed by pathology or biopsy
- For dose escalation: specific tumor types including NSCLC (adenocarcinoma, squamous cell, adenosquamous), urothelial carcinoma, colorectal cancer, prostate adenocarcinoma, epithelial ovarian cancer, and triple-negative breast cancer (TNBC)
- For dose expansion: NSCLC, urothelial carcinoma, colorectal cancer, or tumor types with confirmed response in dose escalation
- Female participants must not be pregnant and follow contraceptive guidance if of childbearing potential
- Participants must have progressed, be intolerant, refuse, or have no standard approved therapies available
- Must have accessible tumor tissue less than 6 months old or undergo mandatory biopsy
- At least one measurable lesion per RECIST v1.1
- ECOG performance status of 0 or 1
- Completed radiotherapy at least 2 weeks prior to study intervention
- Predicted life expectancy of at least 12 weeks
- Adequate organ function before starting study intervention
- Agree not to participate in another interventional study during this study
You will not qualify if you...
- Weigh less than 40 kg
- Ongoing toxicity grade 2 or higher from prior cancer therapies
- Symptomatic or uncontrolled CNS metastases
- Active autoimmune disease, except certain stable conditions
- Recent serious heart conditions or uncontrolled illness
- Corrected QT interval over 470 ms or left ventricular ejection fraction below 45%
- Known HIV infection with low CD4 counts or recent AIDS infections
- Positive hepatitis A, B, or C tests without undetectable viral levels
- History of drug-induced pneumonitis or interstitial lung disease
- Uncontrolled infections, substance abuse, psychiatric illness, or social situations limiting compliance
- Prior allogeneic bone marrow or organ transplant
- Major surgery not recovered within 28 days
- Recent positive COVID-19 antigen test within 10 days
- Received investigational or antineoplastic therapy within 21 days or 5 half-lives
- Required systemic steroids or immunosuppressives within 14 days prior to ASP1002
- Discontinued prior immunotherapy due to severe toxicity
- Expected to require other anticancer therapies during study
- Other malignancies requiring treatment
- Prior anti-CD137 therapy
- Received live vaccines within 28 days prior to study
- Known hypersensitivity to ASP1002 or its components
- Any condition making participation unsuitable
Research Team
A
Astellas Pharma Global Development, Inc.
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