Study on the Safety and Effects of MBRC-101 in Treating Advanced Solid Tumors
Sponsor: MBrace Therapeutics
ClinicalTrials ID:NCT06014658
This clinical trial is testing a new drug, MBRC-101, to see if it is safe and effective for patients with advanced solid tumors that have not responded to standard treatments. The study will explore different doses and monitor the drug's effects on the body.
Patient Parameters
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Program Overview
This study is the first time MBRC-101 is being tested in humans. It aims to find the best dose and understand how the drug works in patients with advanced solid tumors that have not responded to other treatments. The study is divided into three phases: Phase 1 will determine the safest dose, Phase 1b will test the drug's safety and initial effects, and Phase 2 will evaluate how well the drug works against specific types of tumors. Throughout the study, researchers will monitor the safety and effectiveness of MBRC-101 using various medical scans and tests.
Description
The study is divided into three phases:
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Phase 1: This phase will involve about 30 patients with advanced solid tumors that have not responded to standard treatments. The goal is to find the safest dose of MBRC-101. Patients do not need to have a specific tumor marker to join this phase.
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Phase 1b: This phase will expand to include more patients and will test the safety and initial effects of MBRC-101 at the doses identified in Phase 1. It will include three groups of about 20 patients each, focusing on different types of tumors.
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Phase 2: This phase will start once the best dose is determined from Phase 1b. It will focus on a specific type of tumor and involve about 30 patients to evaluate the drug's effectiveness and safety.
Throughout the study, a Safety Review Committee will monitor the safety of the drug. The effectiveness will be measured using medical scans and tests to see how the tumors respond to the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have advanced solid tumors that have not responded to standard treatments.
- Must be able to understand and sign a consent form.
- Women must not be pregnant or breastfeeding and must use effective birth control.
- Men must agree to use effective birth control.
- Must have a life expectancy of at least 3 months.
- Must have adequate blood counts and organ function.
- Must not have received any cancer treatment within 2 weeks before starting the study drug.
- Must provide a tumor sample for analysis, if available.
Exclusion Criteria
- Have severe nerve damage.
- Have uncontrolled cancer spread to the brain.
- Have had a stroke or heart attack within 6 months.
- Have active infections like HIV or hepatitis.
- Have had another cancer within the last 3 years, except for certain skin or prostate cancers.
- Have had major surgery within 28 days before starting the study drug.
- Have any condition that might interfere with the study or pose a risk to the patient.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | 94158 | San Francisco | California |
| Horizon Oncology Research | 47905 | Lafayette | Indiana |
| Rutgers Cancer Institute of New Jersey | 08903 | New Brunswick | New Jersey |
| Carolina BioOncology Institute | 28078 | Huntersville | North Carolina |
| PRISMA Health, Institute for Translational Oncology | 29605 | Greenville | South Carolina |
| NEXT Oncology | 78758 | Austin | Texas |
| NEXT Oncology | 75039 | Irving | Texas |
| NEXT Oncology | 22031 | Fairfax | Virginia |
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