Study on the Safety and Effectiveness of IPN01203 for Adults with Advanced Solid Tumors Previously Treated with Immune Checkpoint Inhibitors
Sponsor: Ipsen
ClinicalTrials ID:NCT07213830
This clinical trial is testing a new drug, IPN01203, to find the right dose and check its safety and effectiveness in adults with advanced solid tumors that have spread or are difficult to treat. The study will also look at how the body processes the drug and its impact on the tumors.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to determine the best dose, safety, and effectiveness of a new drug called IPN01203 in adults with advanced solid tumors. These tumors can occur in various organs and have spread from their original site. The study has two parts: Phase Ia will test different doses to find the most effective and tolerable one, while Phase Ib will explore how well the drug works at slowing or stopping tumor growth and how the body responds to it. An additional phase may be added based on the results. Participants will undergo screening, receive treatment, and have follow-up visits to monitor their health and the drug's effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a measurable tumor that has spread or is locally advanced, confirmed by scans.
- Any side effects from previous treatments must be mild or resolved.
- Have a life expectancy as evaluated by the study doctor.
- Use contraception as per local guidelines if of childbearing potential.
- Have adequate blood and organ function.
- Be able to give informed consent.
Exclusion Criteria
- Have untreated or active brain tumors or cancer spread to the brain or spinal cord.
- Have had severe immune-related side effects from previous cancer treatments.
- Have a history of autoimmune diseases.
- Have had a stroke or significant brain disease in the past year.
- Have had serious heart or lung diseases recently.
- Have had an organ transplant.
- Have active infections or certain viral infections like hepatitis B, C, or HIV unless well-controlled.
- Have had another cancer in the past few years.
- Have uncontrolled medical conditions that could pose a risk.
- Are taking high doses of steroids or immune-suppressing drugs.
- Are participating in another treatment study.
- Are legally institutionalized or under court protection.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| START MidWest PI Sharma | 49546 | Grand Rapids | Michigan |
| Sarah Cannon Research Institute PI McKean Nasville, TN, USA | 37205 | Nashville | Tennessee |
| MD Anderson PI Champiat | 77030 | Houston | Texas |
| Start San Antonio PI Rasco | 78229 | San Antonio | Texas |
| NEXT PI Spira | 22031 | Fairfax | Virginia |
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