Actively Recruiting
A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion 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
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, preliminary effectiveness, and how the body processes DM005, an experimental drug, in people with advanced solid tumors that have spread or progressed despite standard treatments. This first-in-human, open-label study focuses on patients with cancers such as non-small-cell lung cancer, gastroesophageal cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer, and head and neck squamous cell carcinoma. DM005 targets two proteins, c-MET and EGFR, which are involved in tumor growth, and is not yet approved by health authorities for treating these tumors. Participants will receive DM005 through an intravenous infusion on the first day of each 21-day treatment cycle. The first infusion lasts about 60 minutes, with subsequent infusions potentially reduced to 30 minutes if no infusion-related reactions occur. Dose levels vary from 0.5 mg/kg up to 8 mg/kg, and adjustments may be made based on safety and pharmacokinetic data. The study includes a screening period of up to 28 days, followed by treatment cycles, an end-of-treatment visit within 7 days after the last dose, and a follow-up visit about 30 days later. Throughout the study, participants will be closely monitored with safety assessments, including physical exams, laboratory tests, and imaging to measure tumor response. Researchers will track side effects, determine the maximum tolerated dose, and measure drug levels in the blood. The total study involvement includes the screening, multiple treatment cycles, and follow-up, lasting up to 12 months to evaluate dose-limiting toxicities and overall safety.
CONDITIONS
Brief Title
A Study of DM005 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign written informed consent
- Pathologically or cytologically confirmed metastatic or advanced NSCLC, gastroesophageal cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer, or head and neck squamous cell carcinoma not curable by surgery or radiation
- Age 18 years or older at consent
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Life expectancy of at least 3 months
- Measurable disease based on RECIST version 1.1 criteria
You will not qualify if you...
- Another active invasive cancer within 5 years, except certain noninvasive or low-risk cancers in remission
- Current or past hematologic malignancy
- Received anticancer therapy or radiotherapy within 28 days or 5 half-lives before first study dose; major surgery within 4 weeks
- Primary central nervous system malignancies or active/progressive brain metastases; treated, stable brain metastases allowed if off high-dose steroids for at least 4 weeks
- Presence of bulky disease with any mass larger than 7 cm unless approved by medical monitor
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
- Clinically significant corneal disease
- Prolonged 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 not controlled; chronic HBV carriers on prophylaxis may enroll
- Uncontrolled HIV infection; well-controlled HIV allowed with criteria
- Active tuberculosis; positive BCG vaccination with negative IGRA test allowed
- Live vaccine received within 30 days prior to first dose
- Unresolved toxicities from previous anticancer treatments above grade 1 except alopecia and anemia
- Pregnant or breastfeeding females or those intending pregnancy during study
- Refusal to use effective birth control during study and for specified months after last dose administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive DM005 through intravenous infusion on Day 1 every 3 weeks, with dose adjustments possible based on safety and pharmacokinetic data.
1 visit every 3 weeks for infusion
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
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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