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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06475937




Registration number
NCT06475937
Ethics application status
Date submitted
7/06/2024
Date registered
26/06/2024
Date last updated
6/02/2025

Titles & IDs
Public title
A Study of DM001 in Patients with Advanced Solid Tumors
Scientific title
A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients with Advanced Solid Tumors
Secondary ID [1] 0 0
DM001001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Solid Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DM001

Experimental: DM001 administrated to subjects with advanced or metastatic solid tumors - An IV infusion of DM001 will be administrated approximately 30-60 min on Day 1 once Q3W


Treatment: Drugs: DM001
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-limiting Toxicities (DLTs) of DM001
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Maximum tolerated dose (MTD) for DM001
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Area under the plasma concentration-time curve (AUC(0-inf), 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
1. Subjects must have the ability to understand and willingness to sign a written informed consent document.
2. 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.
3. Subjects must be =18 years of age at the time of signing the informed consent form.
4. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Has a life expectancy of =3 months.
6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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.
2. Current or history of a hematologic malignancy.
3. 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.
4. Individuals with Gilbert's disease with =3 × ULN.
5. Has an uncontrolled infection requiring intravenous (IV) injection of antibiotics, antivirals, or antifungals.
6. Has a medical history of clinically significant lung diseases or is suspected to have these diseases by imaging at the screening period.
7. 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.
8. 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.
9. 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.
10. Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.
11. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
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
24/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/02/2027
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [2] 0 0
Tasman Oncology Research - Southport
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
3168 - Clayton
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
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 website
https://clinicaltrials.gov/study/NCT06475937
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zhaorong Chen, CMO
Address 0 0
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xi Cheng
Address 0 0
Country 0 0
Phone 0 0
+86 18066179000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06475937