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OncoMatch/Clinical Trials/NCT06475937

A Study of DM001 in Patients With Advanced Solid Tumors

Is NCT06475937 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies DM001 for breast neoplasms.

Phase 1RecruitingXadcera Biopharmaceutical (Suzhou) Co., Ltd.NCT06475937Data as of May 2026

Treatment: DM001The 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Non-Small Cell Lung Carcinoma

Biomarker criteria

Allowed: EGFR mutation

Allowed: EGFR wild-type

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Cardiac function

Mean resting corrected QT interval (QTcF) >470 msec excluded; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome

Mean resting corrected QT interval corrected by Fridericia's formula (QTcF, QTcF=QT/[RR]1/3) >470 msec obtained from triplicate 12-lead ECGs at baseline; no concomitant medications that would prolong the QT internal; no family history of long QT syndrome.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Sarah Cannon Research Institute (SCRI) · Nashville, Tennessee
  • University of Texas MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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