Study of DM005 for Patients with Advanced Solid Tumors

Sponsor: Doma Biopharmaceutical（Suzhou）Co., Ltd.

Sponsor score: 0

ClinicalTrials ID:NCT06515990

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, DM005, for patients with advanced solid tumors. DM005 is an experimental treatment not yet approved for use. Participants will receive the drug every three weeks and be monitored for safety and how well the treatment works.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety, effectiveness, and tolerability of DM005, an experimental drug, in patients with advanced solid tumors. Participants will go through a screening period of up to 28 days, followed by treatment cycles every 21 days. The drug will be given through an IV infusion, starting with a 60-minute session. If the first dose is well-tolerated, future doses may be given over 30 minutes. After each cycle, safety data will be reviewed to ensure the treatment is safe.

Description

This is the first study in humans to test DM005, a new drug designed to target specific proteins in cancer cells. The study will take place at multiple centers and will involve increasing doses to find the safest and most effective dose. DM005 is a type of drug called a bispecific ADC, which targets proteins called c-MET and EGFR on cancer cells. Participants with advanced solid tumors will receive DM005 every three weeks, with dose adjustments as needed based on safety and how the drug behaves in the body.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to sign a consent form.
  • Have advanced cancers like lung, stomach, colon, liver, pancreatic, or head and neck cancer that cannot be cured with standard treatments and have worsened after standard therapy.
  • Be 18 years or older.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have a life expectancy of at least 3 months.
  • Have measurable disease based on specific criteria.

Exclusion Criteria

  • Have another active cancer within the last 5 years, except for certain non-invasive cancers.
  • Have a history of blood cancers.
  • Have received cancer treatment within 28 days before the study starts.
  • Have untreated or active brain cancer.
  • Have large tumors over 7 cm, unless approved by the study team.
  • Have an uncontrolled infection needing IV treatment.
  • Have significant eye disease.
  • Have heart rhythm issues or a family history of long QT syndrome.
  • Have a heart function below 50%.
  • Have active hepatitis B or C, or uncontrolled HIV.
  • Have active tuberculosis.
  • Have received a live vaccine within 30 days before the study.
  • Have unresolved side effects from previous cancer treatments.
  • Be pregnant or breastfeeding, or planning to become pregnant.
  • Refuse to use effective birth control during and after the study.

Locations

FACILITYZIPCITYSTATE
Henry Ford Cancer Institute48202DetroitMichigan
Sarah Cannon Research Institute at Mary Crowley75251DallasTexas
NEXT Oncology Virginia22031FairfaxVirginia

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