Study on Finding the Right Dose and Safety of a New Treatment for Advanced Solid Tumors

Sponsor: MBrace Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT07145255

Provider View

This clinical trial is testing a new treatment called MBRC-201 for patients with advanced solid tumors that have not responded to standard treatments. The study aims to find the best dose and evaluate the safety and effectiveness of the treatment.

Patient Parameters

Program Overview

This study is exploring a new treatment, MBRC-201, for patients with advanced solid tumors that have not responded to standard treatments. The trial is divided into three phases: Phase 1a will determine the safest and most effective dose, Phase 1b will test the treatment's safety and initial effectiveness, and Phase 2 will further evaluate its impact on tumors. The study will monitor how the body processes the treatment and any immune responses it triggers. A committee will oversee patient safety throughout the study, which is expected to last about four years, with long-term follow-up for safety and health status.

Description

This clinical trial is testing a new treatment called MBRC-201 for patients with advanced solid tumors that have not responded to standard treatments. The study is divided into three phases:

  • Phase 1a: This phase will find the safest and most effective dose of MBRC-201 by gradually increasing the dose in small groups of patients.
  • Phase 1b: This phase will test the safety and initial effectiveness of MBRC-201 at the doses identified in Phase 1a. It will include patients with specific types of cancer, such as prostate, lung, breast, colorectal, and pancreatic cancer.
  • Phase 2: This phase will further evaluate the treatment's impact on tumors in a larger group of patients.

Throughout the study, researchers will monitor how the body processes the treatment and any immune responses it triggers. A committee will oversee patient safety and make recommendations on dosing. The study is expected to last about four years, with long-term follow-up for safety and health status.

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 and must agree to use effective birth control during the study and for six months after.
  • Men must agree to use effective birth control during the study and for six months after.
  • Must have a specific type of cancer, such as prostate, lung, breast, colorectal, or pancreatic cancer.
  • Must have a tumor sample available for analysis, if possible.
  • Must have measurable disease according to specific criteria.
  • Must have a good performance status and life expectancy of at least three months.
  • Must have adequate organ and bone marrow function as determined by blood tests.

Exclusion Criteria

  • History of another cancer within the past three years, except for certain non-threatening cancers.
  • Known allergy to the study drug MBRC-201.
  • Active brain or spinal cord disease related to cancer.
  • Uncontrolled infections or active hepatitis.
  • HIV infection with certain conditions.
  • Recent blood clots or bleeding disorders.
  • Recent heart problems or risk factors for heart rhythm issues.
  • Uncontrolled inflammatory bowel disease or lung disease.
  • Uncontrolled autoimmune diseases.
  • Recent eye diseases that could be worsened by the study.
  • Recent cancer treatments or participation in another clinical trial.
  • Major surgery within the past 28 days.
  • Any condition that could interfere with the study or pose a risk to the patient.

Locations

FACILITYZIPCITYSTATE
START, Midwest49546Grand RapidsMichigan
NEXT, Dallas75039IrvingTexas
START San Antonio78229San AntonioTexas
START, Mountain Region84119West Valley CityUtah
NEXT, Virginia22031FairfaxVirginia

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