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A Study of DM001 in Patients With Advanced Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started2024-10-24
View on ClinicalTrials.gov ↗
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.

Amendment history 3 changes detected by DataLookout

2026-08-29
Enrollment closed, study ongoing
2026-08-29
Primary completion pushed: 2026-08-13 → 2027-01-31
2026-08-29
Completion pushed: 2027-02-13 → 2027-05-31
Trial Details
NCT Number NCT06475937
Lead Sponsor Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Conditions Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Solid Carcinoma
Enrollment 128 participants
Start Date 2024-10-24
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-28