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DM002 in Advanced Solid Tumors
NCT06751329Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2025
- Primary completion
- Oct 2027
- Countries
- 2
- Sponsor
- Xadcera Biopharmaceutical
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Drugs
- DM002
- Conditions
- solid tumorovarian cancerprostate cancer (PCa)endometrial cancer (EC)colorectal cancer (CRC)
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Overview
Phase 2, open-label trial of DM002 in solid tumor, ovarian cancer, prostate cancer (PCa) and 3 more (5 arms), sponsored by Xadcera Biopharmaceutical. Primary endpoints: Dose-limiting Toxicities at 12 months and Maximum Tolerated Dose at 12 months. Started Feb 2025; status: recruiting.
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Design
5 arms- Study design
- Non-randomizedOpen-label
Dose Level 1
1.0 mg/kg DM002 IV Q3W
Dose Level 2
<=2.0 mg/kg DM002 IV Q3W
Dose Level 3
<=3.0 mg/kg DM002 IV Q3W
Dose Level 4
<=4.5 mg/kg DM002 IV Q3W
Dose Level 5
<=6.0 mg/kg DM002 IV Q3W
03
Who it enrols
Adults with advanced solid tumors, ECOG 0-2, adequate organ function, and measurable disease. Excludes patients with prior Topo I ADC treatment, active CNS metastases, or recent other malignancies.
04
Endpoints
Primary
Dose-limiting Toxicities
Maximum Tolerated Dose
Secondary
Area Under the Curve
Maximum Plasma Concentration
Time to Maximum Concentration
Trough Concentration
Objective Response Rate
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