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A Study of DM001 in Patients With Advanced Solid Tumors

NCT06475937 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-04-17

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhaorong Chen, CMO · Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2026-08-13
Completion
2027-02-13
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06475937 on ClinicalTrials.gov