Ovarian NeoplasmsPhase 1/2NCT06751329
A Study of DM002 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing DM002 in people with Ovarian Neoplasms and Prostatic Neoplasms, run by Xadcera Biopharmaceutical (Suzhou) Co., Ltd. at 7 sites in 2 countries.
Trial summary
The goal of study： The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Neoplasms, Prostatic Neoplasms, Endometrial Neoplasms
- What is being tested?
- DM002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 17 Feb 2025to 18 Apr 2028
- Phase
- Phase 1/2
- 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
- Common Inclusion Criteria (Part 1 and Part 2)
- Subjects must have the ability to understand and willingness to sign a written informed consent document.
- 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, 1 or 2.
- Has a life expectancy of ≥3 months.
- Participants must meet the following laboratory values within 7 days prior to first dose of study drug:
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- Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to laboratory assessments at Screening.
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
- Platelet count ≥100 × 10⁹/L;
- Hemoglobin ≥9 g/dL;
- Calculated creatinine clearance (CrCL) >60 mL/min (Cockroft-Gault Equation);
- Total bilirubin ≤ 1.5 x ULN;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), if liver metastases are present, ≤5 × ULN;
- International normalized ratio (INR)<2.0, and prothrombin time and either partial thromboplastin time (PTT) or activated PTT (aPTT) ≤1.5 × ULN, except for participants receiving anti-vitamin K derivative anticoagulant therapy who must have prothrombin time/INR within therapeutic range as deemed appropriate by the Investigator.
- Has measurable disease based on RECIST version 1.1.
- Participants are required to provide tumor tissue specimens obtained within the previous 3 years for the measurement of MUC1 and/or HER3 and other biomarkers. For those subjects who are unable to provide tissue samples will be encouraged (but not mandatory) to undergo biopsy if the risk is manageable. If the biopsy is not possible, it should inform the sponsor for enrolment.
Who cannot join
- Subjects have another active invasive malignancy within 5 years, with the following exceptions and notes:
- History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission 5 years after treatment with curative intent is allowed.
- Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).
- Current or history of a hematologic malignancy.
- Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.
- 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.
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- History of known allergies to ADC, or prior discontinuation of an ADC due to treatment-related toxicities. Has received prior treatment with ADCs that include topoisomerase I (Topo I) payload, and treatment history with any investigational drug within 4 weeks before enrolment in the study.
- Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
- Has a pre-existing clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or pre-existing ocular disorders.
- Clinically uncontrolled intercurrent illness, including but not limited 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) >470 msec obtained from triplicate 12-lead ECGs at baseline; using concomitant medications that would prolong the QT interval.
- Left ventricular ejection fraction <50% by either an echocardiogram (ECHO) or a multi-gated acquisition scan within 28 days before first dose of the study drug.
- Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies/ml or 500 IU/ml) receive prophylactic treatment during the study can be enrolled. Participants 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 ribonucleic acid (RNA) negative due to prior treatment or natural resolution should be eligible.
- Known human immunodeficiency virus (HIV) infection which is not well controlled. Participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)/ethics committee. All the following criteria are required to define an HIV infection (positive HIV1/2 antibodies test) that is well controlled: HIV viral load <400 copies/mL, CD4+ T- cell counts ≥350 cells/μL, no history of acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, and stable viral load for at least 4 weeks on same anti-HIV retroviral medications.
- Subjects who are from endemic areas (refer to WHO high tuberculosis burden country list, China is endemic area) will be specifically screened for tuberculosis with any available test. Subjects with active tuberculosis are excluded. Subjects who have received bacille Calmette-Guerin vaccination may have a false positive result of purified-protein derivative (PPD) test. These subjects are eligible if they have a negative result of interferon gamma release assay (IGRA).
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, ≤Grade 1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to >Grade 2 for at least 3 months prior to enrolment/randomization and managed with the standard treatment) that the Investigator deems related to previous anticancer therapy, following discussion with the Sponsor's medical monitor, such as the following: Grade 2 chemotherapy-induced neuropathy, hypothyroidism, hyperglycemia.
- Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.
- Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.
- Participants who took drugs or food which can strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4/5 within 2 weeks prior to the first dose of DM002 or within 5 half-lives, whichever is longer.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Siqing Fu, 832-817-9581, siqingfu@mdanderson.org
- Recruiting
Carolina BioOncology Institute, LLC
Huntersville, North Carolina, 28078
Hannah Wall, 704-947-6599, hwall@carolinabiooncology.org
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Zachery C Morse, 405-271-8778, Zachery-Morse@ou.edu
- Recruiting
University of California San Francisco Cancer Center
San Francisco, California, 94158
Phu Lam, (415) 476-7931, Phu.Lam@ucsf.edu
Australia3 sites, 3 recruiting
- Recruiting
Southern Oncology Clinical Research Unit
Adelaide, South Australia
Kichenadasse Ganessan, Doctor, 61491679039, ganessan.kichenadasse@socru.org.au
- Recruiting
Scientia Clinical Research
Randwick, New South Wales
Joe Wei, Doctor, 61280374100, joe.wei@scientiaclinicalresearch.com.au
- Recruiting
Cancer Care Wollongong
Wollongong, New South Wales, 2500
UDIT NINDRA, 0437000874, udit.nindra@health.nsw.gov.au
About this study
Official title: A Phase I/IIa, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors
The goal of study：
The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
Read more
In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you.
The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers.
In Part 2, participants will receive the best dose level that was determined in Part 1 of the study.
The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug.
Participants will:
Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.
Read the detailed description
DM002, a bispecific antibody-drug conjugate (ADC) developed using fully human antibodies with a common light chain, which targets MUC1 and HER3.
DM002 is sterile yellowish-green lyophilized powder for intravenous (IV) infusion. Subjects with solid malignant tumors will be treated with DM002 IV on Day 1 once every 3 weeks (Q3W) (dose adjustments may be required depending on the safety profile and PK data of each dose).
- Conditions
- Ovarian Neoplasms, Prostatic Neoplasms, Endometrial Neoplasms, Colorectal Neoplasms, Solid Carcinoma, Pancreatic Cancer
- Being tested
- DM002
- Medical subject headings
- Ovarian Neoplasms, Prostatic Neoplasms, Endometrial Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM002Drug
An IV infusion of DM002 will be administrated approximately 30-60 min on D1 once Q3W
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | 1.0 mg/kg Receives: Drug: DM002 |
| Dose Level 2 | Experimental | ≤2.0 mg/kg Receives: Drug: DM002 |
| Dose Level 3 | Experimental | ≤3.0 mg/kg, Receives: Drug: DM002 |
| Dose Level 4 | Experimental | ≤4.5 mg/kg Receives: Drug: DM002 |
| Dose Level 5 | Experimental | ≤6.0 mg/kg Receives: Drug: DM002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicities (DLTs) of DM002
Incidence of DLTs of DM002 will be determined. A dose-limiting toxicity (DLT) is defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicities.
Measured: 12 months
Maximum tolerated dose (MTD) for DM002
The MTD of DM002 will be determined. The MTD is 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 Curve（AUC，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 posted27 Dec 2024
- Study start17 Feb 2025
- Primary completion8 Oct 2027 (estimated)
- Study completion18 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751329
- Sponsor's protocol ID
- DM002001
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2024
- Last updated
- 7 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06751329
- Acronym / sponsor ID
- DM002001
- Conditions
- Ovarian Neoplasms, Prostatic Neoplasms, Endometrial Neoplasms, Colorectal Neoplasms, Solid Carcinoma, Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Xadcera Biopharmaceutical (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 8 Oct 2027 (estimated)
- Study completion
- 18 Apr 2028 (estimated)
- First posted
- 27 Dec 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 study：
The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you.
The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers.
In Part 2, participants will receive the best dose level that was determined in Part 1 of the study.
The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug.
Participants will:
Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.
Detailed description
DM002, a bispecific antibody-drug conjugate (ADC) developed using fully human antibodies with a common light chain, which targets MUC1 and HER3.
DM002 is sterile yellowish-green lyophilized powder for intravenous (IV) infusion. Subjects with solid malignant tumors will be treated with DM002 IV on Day 1 once every 3 weeks (Q3W) (dose adjustments may be required depending on the safety profile and PK data of each dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: DM0021.0 mg/kg |
| Dose Level 2 | Experimental | Drug: DM002≤2.0 mg/kg |
| Dose Level 3 | Experimental | Drug: DM002≤3.0 mg/kg, |
| Dose Level 4 | Experimental | Drug: DM002≤4.5 mg/kg |
| Dose Level 5 | Experimental | Drug: DM002≤6.0 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Common Inclusion Criteria (Part 1 and Part 2)
- Subjects must have the ability to understand and willingness to sign a written informed consent document.
- 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, 1 or 2.
- Has a life expectancy of ≥3 months.
Key exclusion criteria (20 listed)
- Subjects have another active invasive malignancy within 5 years, with the following exceptions and notes:
- Current or history of a hematologic malignancy.
- Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.
- 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.
- History of known allergies to ADC, or prior discontinuation of an ADC due to treatment-related toxicities. Has received prior treatment with ADCs that include topoisomerase I (Topo I) payload, and treatment history with any investigational drug within 4 weeks before enrolment in the study.
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 |
|---|---|---|
| DM002An IV infusion of DM002 will be administrated approximately 30-60 min on D1 once Q3W | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5 |
Primary outcome
Dose-limiting Toxicities (DLTs) of DM002
Time frame: 12 months
Incidence of DLTs of DM002 will be determined. A dose-limiting toxicity (DLT) is defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicities.
Maximum tolerated dose (MTD) for DM002
Time frame: 12 months
The MTD of DM002 will be determined. The MTD is 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 Curve（AUC，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 7 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.
University of California San Francisco Cancer Center
San Francisco, United States
Carolina BioOncology Institute, LLC
Huntersville, United States
University of Oklahoma Health Sciences Center
Oklahoma City, United States
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DM002 in people with Ovarian Neoplasms and Prostatic Neoplasms, run by Xadcera Biopharmaceutical (Suzhou) Co., Ltd. at 7 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 16 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 7 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 7 sites in United States, Australia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicities (DLTs) of DM002 (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 7 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.