A Study of DM001 in Patients With Advanced Solid Tumors
A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors
1 other identifier
interventional
128
2 countries
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2024
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 26, 2024
CompletedStudy Start
First participant enrolled
October 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 13, 2027
April 17, 2025
February 1, 2025
1.8 years
June 7, 2024
April 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting Toxicities (DLTs) of DM001
Incidence of DLTs of DM001 will be determined. A dose-limiting toxicity (DLT) was defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicity.
12 months
Maximum tolerated dose (MTD) for DM001
The MTD of DM001 will be determined. The MTD was defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose.
12 months
Secondary Outcomes (5)
Area under the plasma concentration-time curve (AUC(0-inf), ng*h/mL)
12 months
Maximum (peak) plasma concentration (Cmax, ng/mL)
12 months
Time to maximum (peak) concentration (Tmax, h)
12 months
Trough concentration (Ctrough, ng/mL)
12 months
Objective response rate (ORR)
12 months
Study Arms (1)
DM001 administrated to subjects with advanced or metastatic solid tumors
EXPERIMENTALAn IV infusion of DM001 will be administrated approximately 30-60 min on Day 1 once Q3W
Interventions
Subjects may continue to receive DM001 (with an increased dose that has been assessed as safe in the dose-escalation period) once every 3 weeks (Q3W) for a total of 6 cycles at the discretion of the investigators, until unacceptable toxicity, progressive disease (PD), or withdrawal of consent.
Eligibility Criteria
You may qualify if:
- Subjects must have the ability to understand and willingness to sign a written informed consent document.
- Subjects who have pathologically or cytologically confirmed documented metastatic/advanced breast cancer, EGFRmut or EGFRwt NSCLC, gastric cancer, gastroesophageal cancer or CRC, and have progressed on standard therapy, or intolerant to standard therapy, or no standard therapy accessible to the subjects due to any reason.
- Subjects must be ≥18 years of age at the time of signing the informed consent form.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of ≥3 months.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
You may not qualify if:
- Subjects have another active invasive malignancy within 5 years.
- Current or history of a hematologic malignancy.
- Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (\>20 mg prednisone or equivalent) for at least 4 weeks.
- Individuals with Gilbert's disease with ≥3 × ULN.
- Has an uncontrolled infection requiring intravenous (IV) injection of antibiotics, antivirals, or antifungals.
- Has a medical history of clinically significant lung diseases or is suspected to have these diseases by imaging at the screening period.
- Clinically uncontrolled intercurrent illness, including but not limit to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.
- Mean resting corrected QT interval corrected by Fridericia's formula (QTcF, QTcF=QT/\[RR\]1/3) \>470 msec obtained from triplicate 12-lead ECGs at baseline; no concomitant medications that would prolong the QT internal; no family history of long QT syndrome.
- Known human immunodeficiency virus infection, or active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Chronic carriers of HBV infection (hepatitis B surface antigen-positive, undetectable, or low HBV DNA) who receive prophylactic treatment during the study can be enrolled. Subjects with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV RNA negative due to prior treatment or natural resolution should be eligible.
- Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.
- Subjects who are of reproductive potential refuse to use effective methods of birth control during the course of participation in the study and within 120 days for both women and men of the last dose are ineligible to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, 37203, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, 4101, Australia
Tasman Oncology Research
Southport, Queensland, 4215, Australia
Monash Health
Clayton, Victoria, 3168, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhaorong Chen, CMO
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2024
First Posted
June 26, 2024
Study Start
October 24, 2024
Primary Completion (Estimated)
August 13, 2026
Study Completion (Estimated)
February 13, 2027
Last Updated
April 17, 2025
Record last verified: 2025-02