OncoMatch/Clinical Trials/NCT06515990
A Study of DM005 in Patients With Advanced Solid Tumors
Is NCT06515990 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies DM005 for carcinoma, non-small-cell lung.
Treatment: DM005 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapy
have progressed on standard therapy, or intolerant to standard therapy
Cannot have received: anticancer therapy
Exception: hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels
Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose.
Cannot have received: radiotherapy
Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose.
Cannot have received: major surgery
Exception: diagnostic surgery
Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.
Lab requirements
Cardiac function
Left ventricular ejection fraction (LVEF) <50% by either an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan within 28 days before first dose of the study drug. Has a corrected QT interval (QTcF) prolongation to >470 ms (for both genders) based on average of the Screening triplicate 12-lead ECG determinations; no concomitant medications that would prolong the QT interval; no known family history of long QT syndrome.
Left ventricular ejection fraction (LVEF) <50% ... QTcF prolongation to >470 ms ... no concomitant medications that would prolong the QT interval; no known family history of long QT syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Henry Ford Cancer Institute · Detroit, Michigan
- Sarah Cannon Research Institute at Mary Crowley · Dallas, Texas
- NEXT Oncology Virginia · Fairfax, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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