Actively Recruiting
A Phase I, Open-label, First-in-Human Study of DM002 with Dose Escalation and Expansion in Patients With Advanced Solid Tumors
Led by Xadcera Biopharmaceutical (Suzhou) Co., Ltd. · Updated on 2026-01-15
160
Participants Needed
5
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DM002, a bispecific antibody-drug conjugate designed to target MUC1 and HER3, in people with advanced solid tumors such as ovarian, prostate, endometrial, colorectal cancers, and other solid carcinomas. The study is divided into two parts: Part 1 focuses on testing increasing doses to find the safest and most effective amount, while Part 2 uses the best dose from Part 1 to further assess safety and how the cancer responds. This Phase I, open-label trial aims to understand how the body processes DM002 and to monitor any side effects at different dose levels. Participants will receive DM002 as an intravenous infusion once every three weeks, with doses ranging from 1.0 mg/kg up to 7.5 mg/kg. Part 1 involves dose escalation across up to six or more groups to evaluate safety and tolerability. In Part 2, participants receive the selected optimal dose determined from Part 1. The treatment cycles last 21 days each, and dose adjustments may occur based on safety and pharmacokinetic data. DM002 is provided as a sterile lyophilized powder for infusion. Participants will attend at least 17 visits, starting with a screening phase lasting up to 28 days. Treatment cycles occur every 21 days, followed by an End of Treatment visit 21 days after the last dose and a Follow-up visit 30 days later. Telephone check-ins will continue every three months to monitor wellbeing and any new anticancer treatments started. Researchers will measure dose-limiting toxicities, maximum tolerated dose, drug levels in the blood, and cancer response using objective measures over 12 months.
CONDITIONS
Brief Title
A Study of DM002 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent
- Age 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Life expectancy of at least 3 months
- Laboratory values within 7 days before first dose: ANC ≥1.5 x10⁹/L, Platelet count ≥100 x10⁹/L, Hemoglobin ≥9 g/dL, Creatinine clearance >60 mL/min, Total bilirubin ≤1.5 x ULN, AST and ALT ≤3.0 x ULN (≤5.0 x ULN if liver metastases present), INR <2.0 and coagulation times ≤1.5 x ULN
- Measurable disease based on RECIST version 1.1
- Provide tumor tissue specimens from past 3 years for biomarker testing or undergo biopsy if possible
You will not qualify if you...
- Another active invasive malignancy within 5 years except certain treated noninvasive cancers
- History or current hematologic malignancy
- Anticancer therapy within 28 days or 5 half-lives before study dose
- Recent radiotherapy or major surgery within specified timeframes
- Primary CNS malignancies or untreated/progressive brain metastases
- Allergies to antibody-drug conjugates or prior ADC treatment with specific payload
- Uncontrolled infections requiring IV antibiotics or antivirals
- Pre-existing significant lung or eye diseases
- Uncontrolled illnesses including infection, cardiovascular, immune, diabetes, effusions, psychiatric illness
- QTcF >470 msec or medications prolonging QT interval
- Left ventricular ejection fraction <50%
- Active hepatitis B or C infection not meeting criteria
- Uncontrolled HIV infection
- Active tuberculosis
- Live vaccine within 30 days prior to first dose
- Unresolved toxicities from previous cancer therapies above grade 1 except stable chronic grade 2
- Pregnancy, lactation, or refusal to use effective contraception
- Use of strong CYP3A4/5 inhibitors or inducers within 2 weeks prior to first dose or 5 half-lives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive intravenous infusions of DM002 once every 3 weeks with dose adjustments based on safety and pharmacokinetic data.
1 visit every 3 weeks for infusion
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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