Study of TAK-505 in Adults with Solid Tumors
Sponsor: Takeda
ClinicalTrials ID:NCT07436728
This clinical trial is testing a new drug, TAK-505, in adults with certain types of solid tumors, such as stomach, colorectal, lung, and head and neck cancers. The study aims to determine the safety, effectiveness, and best dose of TAK-505, as well as how it moves through the body and affects the immune system.
Patient Parameters
| Parameter | Options |
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Program Overview
Solid tumors are lumps of cancer cells that can form in organs or tissues like the lung or liver. These tumors can grow locally or spread to other parts of the body, making them hard to remove with surgery. This study is the first time TAK-505 is being tested in humans. It involves a small group of adults with specific types of solid tumors, including stomach, colorectal, lung, and head and neck cancers. The main goals are to see how safe TAK-505 is, how well it works, how patients tolerate it, and to find the best dose with the least side effects. The study also looks at how TAK-505 moves through the body, its ability to shrink or slow cancer, and if it triggers an immune response.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Have advanced or metastatic solid tumors like stomach, colorectal, lung, or head and neck cancer.
- Tumors must be confirmed by lab tests and have no other effective treatment options.
- For lung cancer, must have received certain chemotherapy and immunotherapy treatments.
- For colorectal cancer, must have tried specific treatments and have no more than four prior therapies.
- For stomach cancer, must have tried specific treatments and have no more than three prior therapies.
- Tumors must be PD-L1 positive.
- Must provide a recent tumor sample.
- Must have a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
- Must have at least one measurable tumor.
- Must have adequate blood cell counts and organ function.
- Must have recovered from previous treatment side effects.
- Must have suitable veins for blood sampling.
- Any brain metastases must be treated and stable.
Exclusion Criteria
- History of autoimmune diseases, except for certain conditions like vitiligo or well-controlled diabetes.
- Recent heart problems or severe lung conditions.
- Active infections or low oxygen levels.
- Recent gastrointestinal issues like bleeding or pancreatitis.
- Recent live vaccinations.
- Recent organ transplants or bone marrow transplants.
- Known allergies to TAK-505 or its ingredients.
- Other active cancers not in remission for at least three years.
- Positive for HIV or hepatitis B or C.
- Recent treatments with certain cancer therapies.
- Use of immunosuppressive medications recently.
- Recent major surgery or unhealed wounds.
- Pregnant or breastfeeding women.
- Not willing to use effective contraception.
- Unable to comply with study visits and procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCI Health | 92868 | Orange | California |
| University of California San Diego Medical Center, La Jolla | 92093 | San Diego | California |
| University of California San Francisco | 94143 | San Francisco | California |
| H Lee Moffitt Cancer Center | 33612 | Tampa | Florida |
| Univeristy of Minnesota | 55455 | Minneapolis | Minnesota |
| Icahn School of Medicine at Mount Sinai | 10029 | New York | New York |
| Cleveland Clinic Foundation | 44195 | Cleveland | Ohio |
| Sarah Cannon Research Institute SCRI | 37203 | Nashville | Tennessee |
| Tennessee Oncology | 37203 | Nashville | Tennessee |
| Mary Crowley Cancer Center | 75230 | Dallas | Texas |
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