Actively Recruiting
A Study of DM005 in Patients With Advanced Solid Tumors
Led by Doma Biopharmaceutical（Suzhou）Co., Ltd. · Updated on 2026-01-15
136
Participants Needed
6
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit. Participants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.
CONDITIONS
Official Title
A Study of DM005 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older and able to understand and sign informed consent.
- Participants must have pathologically or cytologically confirmed metastatic or advanced non-small-cell lung cancer, gastroesophageal cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer, or head and neck squamous cell carcinoma.
- Disease must be not curable with standard local therapies and progressed on or intolerant to standard therapy.
- Eastern Cooperative Oncology Group performance status must be 0 to 2.
- Life expectancy must be at least 3 months.
- Participants must have measurable disease based on RECIST version 1.1.
You will not qualify if you...
- Active invasive malignancy within 5 years, except certain in situ or localized cancers in complete remission.
- Current or history of hematologic malignancy.
- Anticancer therapy or radiotherapy within 28 days (or shorter based on half-life), or major surgery within 4 weeks before first study dose.
- Primary central nervous system malignancies or progressing CNS metastases; treated, stable brain metastases allowed under conditions.
- Presence of any mass greater than 7 cm unless approved by medical monitor.
- Uncontrolled infections requiring intravenous antimicrobial treatment.
- Clinically significant corneal disease.
- Corrected QT interval over 470 ms or family history of long QT syndrome.
- Left ventricular ejection fraction below 50% within 28 days before first dose.
- Active hepatitis B or C infection unless controlled or treated as specified.
- Uncontrolled HIV infection.
- Active tuberculosis or positive tuberculosis screening without negative confirmatory testing.
- Live vaccine within 30 days prior to first dose.
- Unresolved toxicities from prior anticancer therapy above grade 1 except stable chronic grade 2 toxicities.
- Pregnant or lactating females or those intending to become pregnant.
- Participants of reproductive potential not agreeing to effective contraception during and after study as specified.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202
Actively Recruiting
2
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States, 75251
Actively Recruiting
3
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
4
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Actively Recruiting
5
Macquarie University Hospital
North Ryde, New South Wales, Australia
Actively Recruiting
6
ICON Cancer Center
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
Research Team
W
Wenjun Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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