A Study of DM001 for Advanced Solid Tumors

This study is testing an experimental drug called DM001 for people with advanced solid tumors, including breast cancer, non-small cell lung cancer, and other solid cancers. DM001 is a bispecific antibody-drug conjugate (ADC), meaning it's designed to target two specific markers (TROP2 and EGFR) on cancer cells. The main goals are to find out how safe DM001 is, what dose is best tolerated, and if it shows any early signs of working. You might be able to join if your cancer has progressed after standard treatments or if you can't tolerate those treatments. The study is currently unclear on its recruitment status and plans to enroll 128 participants.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know you are receiving DM001. It aims to enroll 128 participants.
What's involved
You would have up to 17 visits over the course of the study, starting with a 4-week screening period. Treatment cycles are every three weeks, with more frequent visits early on.
Compensation
Not stated in the trial record.
Follow-up
After your last dose of DM001, you will have an End of Treatment visit about 21 days later, followed by a final follow-up visit about 30 days after that.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06475937

A Study of DM001 in Patients With Advanced Solid Tumors

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
~128 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:DM001

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting Toxicities (DLTs) of DM001
Measured over 12 months
+1 more outcome measured
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Solid Carcinoma
5 sites across 4 states
Queensland2
Tennessee1
Texas1
Victoria1
  • Zhaorong Chen, CMO · STUDY_CHAIR · Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Dose-limiting Toxicities (DLTs) of DM00112 months

    Incidence of DLTs of DM001 will be determined. A dose-limiting toxicity (DLT) was defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicity.

  • Maximum tolerated dose (MTD) for DM00112 months

    The MTD of DM001 will be determined. The MTD was defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose.