Study of DECOY20 with or Without Tislelizumab in Patients with Advanced Solid Tumors
Sponsor: Indaptus Therapeutics, Inc
ClinicalTrials ID:NCT05651022
This clinical trial is testing a new treatment called Decoy20, alone or with another drug, Tislelizumab, to see if it is safe and effective for patients with advanced solid tumors.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if Decoy20, a new cancer treatment, is safe and works well for patients with advanced solid tumors. It will be tested alone and in combination with Tislelizumab, another cancer drug. The trial is divided into two parts: the first part will determine the best dose of Decoy20, and the second part will test this dose in more patients to confirm its safety and effectiveness. Patients with certain types of advanced cancer, such as liver, colorectal, bladder, head and neck, pancreatic, and lung cancer, may be eligible to participate.
Description
Decoy20 is a new type of cancer treatment that works by stimulating the immune system to fight cancer. This study is being conducted in two phases to evaluate its safety and effectiveness in patients with advanced solid tumors.
In the first phase, patients will receive a single dose of Decoy20 at different levels to find the safest dose. This phase will help determine the best dose to use in the second phase.
In the second phase, the study will test the chosen dose of Decoy20 in more patients to confirm its safety and effectiveness. This phase is divided into three parts:
- Part 2a: A small group of patients will receive weekly doses of Decoy20 to check for any side effects.
- Part 2b: More patients will receive the same dose to further evaluate its safety and how well it works.
- Part 2c: Decoy20 will be combined with Tislelizumab to see if the combination is safe and effective.
Throughout the study, a team of experts will review the data to ensure patient safety and determine the best dose for future studies.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Diagnosed with advanced or metastatic solid tumors, including liver, colorectal, bladder, head and neck, pancreatic, and lung cancer.
- Have tried all available treatments or cannot receive them.
- Have at least one measurable tumor.
- Good overall health with a performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Women must not be able to become pregnant or agree to use effective birth control during and after treatment.
- Men must agree to use birth control during and after treatment.
- Have good organ function based on lab tests.
- Heart function must be adequate.
- Recovered from previous treatments.
- Willing to follow study procedures and attend all visits.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Have an active infection requiring treatment.
- Received recent radiation or chemotherapy.
- Taking high doses of steroids.
- Have cancer that has spread to the brain or spinal cord unless stable.
- Have blood clotting issues or recent blood clots.
- Have another active cancer.
- Have certain infections like HIV or hepatitis.
- Have severe liver disease or have had a liver transplant.
- Have received a vaccine recently.
- Have an autoimmune disease.
- Have severe lung disease or low oxygen levels.
- Have heart problems or recent heart attack.
- Have had major surgery recently.
- Have a condition that increases risk during the study.
- Have an allergy to Decoy20.
- For Part 2c, have ongoing side effects from previous treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Southern California- Norris Cancer Center | 90033 | Los Angeles | California |
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| Winship Cancer Institute of Emory University | 30322 | Atlanta | Georgia |
| The Barbara Ann Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| Washington University, Siteman Cancer Center | 63108 | St. Louis | Missouri |
| Atlantic Health System | 07960 | Morristown | New Jersey |
| Gabrail Cancer & Research Center | 44718 | Canton | Ohio |
| Cleveland Clinic Taussig Cancer Center | 44195 | Cleveland | Ohio |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
| Prisma Health Cancer Institute-ITOR | 29605 | Greenville | South Carolina |
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