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NCT06515990 · ClinicalTrials.gov record · last posted 2026-08-07

A Study of DM005 in Patients With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started2024-10-31
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from the ClinicalTrials.gov record
The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit. Participants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.

Protocol amendment history 5 changes detected by DataLookout

2026-08-08
notable
Phase changed: Phase 1 → Phase 1/2
2026-08-08
notable
Enrollment increased: 136 → 208 participants
2026-08-08
minor
Trial arms changed: 6 → 9
2026-08-08
notable
Primary completion pushed: 2026-10 → 2027-03
2026-08-08
minor
Completion pushed: 2027-03 → 2027-09
Trial Details
NCT Number NCT06515990
Lead Sponsor Doma Biopharmaceutical(Suzhou)Co., Ltd.
Conditions Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Solid Carcinoma
Enrollment 208 participants
Start Date 2024-10-31
Primary Completion 2027-03 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-07