NCT06751329

A Study of DM002 in Patients With Advanced Solid Tumors

A Phase I, Multicentre, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Xadcera Biopharmaceutical (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

DM002, a bispecific antibody-drug conjugate (ADC) developed using fully human antibodies with a common light chain, which targets MUC1 and HER3. DM002 is sterile yellowish-green lyophilized powder for intravenous (IV) infusion. Subjects with solid malignant tumors will be treated with DM002 IV on Day 1 once every 3 weeks (Q3W) (dose adjustments may be required depending on the safety profile and PK data of each dose).

Conditions

• Ovarian Neoplasms
• Prostatic Neoplasms
• Endometrial Neoplasms
• Colorectal Neoplasms
• Solid Carcinoma

Interventions

Type	Name	Description
DRUG	DM002	An IV infusion of DM002 will be administrated approximately 30-60 min on D1 once Q3W

Timeline

• Start date: 2025-02-17
• Primary completion: 2027-10-08
• Completion: 2028-04-18
• First posted: 2024-12-27
• Last updated: 2026-01-15

Locations

5 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study