Breast NeoplasmsPhase 1NCT06475937
A Study of DM001 in Patients With Advanced Solid Tumors
A Phase 1 study testing DM001 in people with Breast Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Xadcera Biopharmaceutical (Suzhou) Co., Ltd. at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Solid Carcinoma
- What is being tested?
- DM001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 24 Oct 2024to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia3 sites
Monash Health
Clayton, Victoria, 3168
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, 4101
Tasman Oncology Research
Southport, Queensland, 4215
United States2 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, 37203
About this study
Official title: A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors
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.
Read the detailed description
This is a Phase 1, multicenter, openlabel, first-in-human (FIH), doseescalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of DM001 in subjects with advanced solid tumors.
DM001, a bispecific ADC developed using fully human antibodies with a common light chain, which targets TROP2 and EGFR.
DM001 is sterile yellowish-green lyophilized powder for IV infusion.
Subjects with solid malignant tumors will be treated with DM001 on Day 1 once Q3W (dose adjustments may be required depending on the safety profile and PK data of each dose).
- Being tested
- DM001
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM001Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| DM001 administrated to subjects with advanced or metastatic solid tumors | Experimental | An IV infusion of DM001 will be administrated approximately 30-60 min on Day 1 once Q3W Receives: Drug: DM001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (5)
Area under the plasma concentration-time curve (AUC(0-inf), ng*h/mL)
Area under the plasma concentration-time curve from time zero extrapolated to infinity, calculated by linear up/log down trapezoidal summation.
Measured: 12 months
Maximum (peak) plasma concentration (Cmax, ng/mL)
Maximum concentration, obtained directly from the observed concentration versus time data.
Measured: 12 months
Time to maximum (peak) concentration (Tmax, h)
Time to Cmax
Measured: 12 months
Trough concentration (Ctrough, ng/mL)
The lowest plasma concentration reached before the next dose.
Measured: 12 months
Objective response rate (ORR)
ORR is defined as the number of patients with at least a confirmed complete response (CR) or partial response (PR), based on the best objective response values while on treatment using RECIST version 1.1
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start24 Oct 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaorong Chen, CMO, Study chair, Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475937
- Sponsor's protocol ID
- DM001001
- Status last verified
- Aug 2026
- First submitted
- 7 Jun 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06475937
- Acronym / sponsor ID
- DM001001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Xadcera Biopharmaceutical (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, multicenter, openlabel, first-in-human (FIH), doseescalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of DM001 in subjects with advanced solid tumors.
DM001, a bispecific ADC developed using fully human antibodies with a common light chain, which targets TROP2 and EGFR.
DM001 is sterile yellowish-green lyophilized powder for IV infusion.
Subjects with solid malignant tumors will be treated with DM001 on Day 1 once Q3W (dose adjustments may be required depending on the safety profile and PK data of each dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DM001 administrated to subjects with advanced or metastatic solid tumors | Experimental | Drug: DM001An IV infusion of DM001 will be administrated approximately 30-60 min on Day 1 once Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM001Subjects 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. | Drug | DM001 administrated to subjects with advanced or metastatic solid tumors |
Primary outcome
Dose-limiting Toxicities (DLTs) of DM001
Time frame: 12 months
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.
Maximum tolerated dose (MTD) for DM001
Time frame: 12 months
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.
5 secondary outcomes
Area under the plasma concentration-time curve (AUC(0-inf), ng*h/mL)
Time frame: 12 months
Maximum (peak) plasma concentration (Cmax, ng/mL)
Time frame: 12 months
Time to maximum (peak) concentration (Tmax, h)
Time frame: 12 months
Trough concentration (Ctrough, ng/mL)
Time frame: 12 months
Objective response rate (ORR)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaorong Chen, CMO study chair
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DM001 in people with Breast Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Xadcera Biopharmaceutical (Suzhou) Co., Ltd. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicities (DLTs) of DM001 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.