Trial Review

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06751329




Registration number
NCT06751329
Ethics application status
Date submitted
11/12/2024
Date registered
27/12/2024
Date last updated
17/04/2025

Titles & IDs
Public title
A Study of DM002 in Patients With Advanced Solid Tumors
Scientific title
A Phase I, Multicentre, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
DM002001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasms 0 0
Prostatic Neoplasms 0 0
Endometrial Neoplasms 0 0
Colorectal Neoplasms 0 0
Solid Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DM002

Experimental: Dose Level 1 - 1.0 mg/kg

Experimental: Dose Level 2 - =2.0 mg/kg

Experimental: Dose Level 3 - =3.0 mg/kg,

Experimental: Dose Level 4 - =4.5 mg/kg

Experimental: Dose Level 5 - =6.0 mg/kg

Experimental: Dose Level 6 - =7.5 mg/kg


Treatment: Drugs: DM002
An IV infusion of DM002 will be administrated approximately 30-60 min on D1 once Q3W
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-limiting Toxicities (DLTs) of DM002
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Maximum tolerated dose (MTD) for DM002
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Area Under the Curve(AUC,ng·h/mL)
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Maximum (peak) plasma concentration (Cmax, ng/mL)
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Time to maximum (peak) concentration (Tmax, h)
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Trough concentration (Ctrough, ng/mL)
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Objective response rate (ORR)
Timepoint [5] 0 0
12 months

Eligibility
Key inclusion criteria
Common Inclusion Criteria (Part 1 and Part 2)

1. Subjects must have the ability to understand and willingness to sign a written informed consent document.
2. Subjects must be =18 years of age at the time of signing the informed consent form.
3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
4. Has a life expectancy of =3 months.
5. Participants must meet the following laboratory values within 7 days prior to first dose of study drug:

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 × 10?/L;
* Platelet count =100 × 10?/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.
6. Has measurable disease based on RECIST version 1.1.
7. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects have another active invasive malignancy within 5 years, with the following exceptions and notes:

1. 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.
2. Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).
2. Current or history of a hematologic malignancy.
3. 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.
4. 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.
5. 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.
6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
7. Has a pre-existing clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or pre-existing ocular disorders.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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).
14. Has received a live vaccine within 30 days prior to the first dose of study drug.
15. 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.
16. Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.
17. 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.
18. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/04/2028
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Cancer Care Wollongong - Wollongong
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06751329