Actively Recruiting
A Study of DM002 in Patients With Advanced Solid Tumors
Led by Xadcera Biopharmaceutical (Suzhou) Co., Ltd. · Updated on 2026-01-15
160
Participants Needed
5
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of DM002 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- 18 years of age or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of at least 3 months
- Laboratory values within 7 days prior to first dose: ANC 1.5 x 10^9/L, Platelet count 100 x 10^9/L, Hemoglobin 9 g/dL, Creatinine clearance >60 mL/min, Total bilirubin 1.5 x ULN, AST and ALT 3.0 x ULN (or 5 x ULN if liver metastases present), INR <2.0 and coagulation tests 1.5 x ULN unless on anticoagulants with therapeutic range
- Measurable disease based on RECIST version 1.1
- Able to provide tumor tissue samples within previous 3 years for biomarker measurement or willing to undergo biopsy if safe
You will not qualify if you...
- Another active invasive malignancy within 5 years, except certain treated noninvasive cancers in remission
- Current or past hematologic malignancy
- Anticancer therapy within 28 days or 5 half-lives before first dose
- Radiotherapy within 28 days (wide field) or 14 days (limited field for palliation)
- Major surgery within 4 weeks before first dose
- Primary CNS malignancies or untreated/progressive brain metastases
- Known allergies to antibody-drug conjugates or prior discontinuation due to related toxicities
- Prior treatment with ADCs containing topoisomerase I payloads or investigational drugs within 4 weeks
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Pre-existing significant lung or eye diseases
- Uncontrolled illnesses including infections, coagulopathy, cardiovascular, immune, diabetes, effusions, psychiatric illness
- QTcF interval >470 msec or use of medications prolonging QT interval
- Left ventricular ejection fraction <50%
- Active hepatitis B or C infection not controlled; HIV infection not well controlled
- Active tuberculosis
- Live vaccine within 30 days before first dose
- Unresolved toxicities from previous cancer therapy above grade 1 except stable chronic grade 2
- Pregnant or lactating females
- Refusal to use effective birth control during and after study
- Use of strong CYP3A4/5 inhibitors or inducers within 2 weeks before first dose or 5 half-lives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73190
Actively Recruiting
2
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
Scientia Clinical Research
Randwick, New South Wales, Australia
Actively Recruiting
4
Cancer Care Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
5
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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