Study on STAR0602 for Treating Advanced Solid Tumors

Sponsor: Marengo Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05592626

Provider View

This clinical trial is testing a new drug, STAR0602, to see if it is safe and effective for treating advanced solid tumors that have a lot of specific proteins. The study involves giving the drug through an IV to participants and monitoring their response.

Patient Parameters

Program Overview

The study aims to evaluate the safety and initial effectiveness of a new drug called STAR0602 in patients with advanced solid tumors that have a high amount of certain proteins. The trial is divided into two parts: Phase 1, where the focus is on finding a safe dose, and Phase 2, where the drug's effectiveness is further tested at the determined dose. Researchers will look at how well the tumors respond to the treatment, how long the response lasts, and how the disease progresses over time.

Description

This clinical trial is divided into two phases. In Phase 1, the goal is to determine the safest dose of STAR0602 by gradually increasing the amount given to participants with advanced solid tumors. This phase will help identify the maximum dose that can be tolerated without severe side effects. In Phase 2, the study will use the dose found in Phase 1 to treat more participants and further evaluate the drug's effectiveness. Researchers will measure how well the tumors respond to the treatment, how long the response lasts, and how the disease progresses. The study will also monitor the safety and side effects of STAR0602 throughout the trial.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of solid tumors that cannot be surgically removed, have spread locally, or have metastasized, and for which no standard treatments are available or effective.
  • For Phase 1, must have one of the following types of tumors:
    • High mutational burden (TMB-H)
    • Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
    • Virally associated tumors
  • For Phase 2, must have one of the following types of tumors:
    • TMB-H
    • MSI-H/dMMR
    • Virally associated tumors
    • Metastatic triple negative breast cancer
    • Relapsed and refractory epithelial ovarian cancer
    • Metastatic castration-resistant prostate cancer
    • K-Ras wild type colorectal cancer (CRC)
    • K-Ras mutant CRC
    • Primary stage IV or recurrent non-small cell lung cancer
  • Any brain metastases must have been treated, be symptom-free for at least 14 days, and meet specific conditions at enrollment:
    • No ongoing treatment for brain disease
    • No leptomeningeal disease or spinal cord compression

Exclusion Criteria

  • Have a history of autoimmune diseases, except for:
    • Vitiligo
    • Psoriasis or other skin conditions not needing systemic treatment
    • Graves' disease, now stable
    • Hypothyroidism managed with thyroid replacement
    • Alopecia
    • Arthritis managed without strong medications
    • Well-controlled adrenal insufficiency
  • Major surgery or injury within 8 weeks before starting the study drug
  • Unhealed wounds from surgery or injury
  • Use of more than 10 mg per day of prednisone or other immune-suppressing drugs within 7 days before starting the study drug, with some exceptions
  • Significant heart, digestive, inflammatory, or lung issues
  • Active infections needing IV treatment within 7 days before starting the study drug
  • Recent vaccination with live virus vaccines within 4 weeks before starting the study drug (annual flu shots are allowed)
  • Known HIV or hepatitis B or C with uncontrolled disease
  • Another invasive cancer not in remission for at least 1 year, with some exceptions
  • Pregnant, likely to become pregnant, or breastfeeding women

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