Actively Recruiting
A Study of DM001 in Patients With Advanced Solid Tumors
Led by Xadcera Biopharmaceutical (Suzhou) Co., Ltd. · Updated on 2025-04-17
128
Participants Needed
5
Research Sites
120 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 DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. Participants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit.
CONDITIONS
Official Title
A Study of DM001 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to sign a written informed consent document
- Pathologically or cytologically confirmed metastatic/advanced breast cancer, EGFR-mutated or EGFR wild-type non-small-cell lung cancer, gastric cancer, gastroesophageal cancer, or colorectal cancer
- Disease progressed on standard therapy, intolerant to standard therapy, or no standard therapy accessible
- Age 18 years or older at informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Measurable disease based on RECIST version 1.1
You will not qualify if you...
- Another active invasive malignancy within the last 5 years
- Current or history of hematologic malignancy
- Primary central nervous system malignancies or untreated/progressive CNS metastases
- Gilbert's disease with bilirubin levels 3 times above the upper limit of normal
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
- Clinically significant lung disease or suspicion of lung disease by imaging
- Uncontrolled intercurrent illnesses such as active infection, coagulopathy, cardiovascular disease, immune disease, diabetes, pleural or peritoneal effusion, serious psychiatric illness, or other serious medical conditions requiring systemic therapy
- Corrected QT interval (QTcF) greater than 470 msec at baseline
- Known HIV infection or active hepatitis B or C infection (except controlled chronic HBV or resolved HCV)
- Pregnant or lactating females or intending to become pregnant during the study
- Refusal to use effective birth control during the study and for 120 days after the last dose for participants of reproductive potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States, 37203
Actively Recruiting
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
4
Tasman Oncology Research
Southport, Queensland, Australia, 4215
Actively Recruiting
5
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
Research Team
X
Xi Cheng
CONTACT
L
Lingying Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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