Study on DM002 for Patients with Advanced Solid Tumors

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

Sponsor score: 0

ClinicalTrials ID:NCT06751329

Provider View

This clinical trial is testing a new drug, DM002, to find the safest and most effective dose for treating advanced solid tumors. The study is divided into two parts: the first part tests different doses, and the second part uses the best dose found to see how well it works against cancer.

Patient Parameters

Program Overview

The study is designed to test a new drug called DM002 in patients with advanced solid tumors. It has two parts: Part 1 focuses on finding the safest dose by gradually increasing the amount given to participants. Part 2 uses the best dose from Part 1 to see how well it works in treating cancer. Participants will visit the study center at least 17 times, with a screening phase lasting up to 28 days and treatment cycles every 21 days. After the treatment ends, there will be follow-up visits to monitor participants' health and any new cancer treatments they may start.

Description

DM002 is a new type of drug called a bispecific antibody-drug conjugate (ADC) that targets specific proteins on cancer cells, MUC1 and HER3. It is given as an intravenous (IV) infusion every three weeks. The study will adjust doses based on safety and how the drug behaves in the body. Participants will receive the drug on Day 1 of each 21-day cycle. The study aims to find the best dose and see how well it works in shrinking tumors. Participants will have regular visits to the study center for treatment and monitoring.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Must be 18 years or older.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must have a life expectancy of at least 3 months.
  • Must meet specific blood test requirements before starting the study.
  • Must have measurable cancer based on standard criteria.
  • Must provide a recent tumor tissue sample for testing, if possible.

Exclusion Criteria

  • Have another active cancer within the last 5 years, except for certain non-threatening types.
  • Have a history of blood cancers.
  • Have received certain cancer treatments recently.
  • Have untreated or active brain cancer.
  • Have allergies to similar drugs or have stopped similar treatments due to side effects.
  • Have an uncontrolled infection requiring IV treatment.
  • Have significant lung or eye diseases.
  • Have uncontrolled medical conditions or psychiatric illnesses.
  • Have a heart condition affecting the heart's pumping ability.
  • Have active hepatitis B or C, or uncontrolled HIV.
  • Have active tuberculosis.
  • Have received a live vaccine recently.
  • Have unresolved side effects from previous cancer treatments.
  • Are pregnant, breastfeeding, or planning to become pregnant.
  • Are not willing to use effective birth control during and after the study.
  • Have taken certain drugs that affect how the body processes DM002 recently.

Locations

FACILITYZIPCITYSTATE
University of Oklahoma Health Sciences Center73190Oklahoma CityOklahoma
The University of Texas, MD Anderson Cancer Center77030HoustonTexas

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