NCT06475937

A Study of DM001 in Patients With Advanced Solid Tumors

A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Xadcera Biopharmaceutical (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1, multicenter, openlabel, first-in-human (FIH), doseescalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of DM001 in subjects with advanced solid tumors. DM001, a bispecific ADC developed using fully human antibodies with a common light chain, which targets TROP2 and EGFR. DM001 is sterile yellowish-green lyophilized powder for IV infusion. Subjects with solid malignant tumors will be treated with DM001 on Day 1 once Q3W (dose adjustments may be required depending on the safety profile and PK data of each dose).

Conditions

• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Solid Carcinoma

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-10-24
• Primary completion: 2026-08-13
• Completion: 2027-02-13
• First posted: 2024-06-26
• Last updated: 2025-04-17

Locations

5 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study