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RECRUITING Phase 1

A Study of DM005 in Patients With Advanced Solid Tumors

NCT06515990 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG DM005

Study Locations (6)

New South Wales

  • Chris O'Brien Lifehouse — Camperdown
  • Macquarie University Hospital — North Ryde

Michigan

  • Henry Ford Cancer Institute — Detroit

Texas

  • Sarah Cannon Research Institute at Mary Crowley — Dallas

Virginia

  • NEXT Oncology Virginia — Fairfax

Queensland

  • ICON Cancer Center — South Brisbane

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2024-10-31
Est. Completion 2027-03
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06515990

The ClinicalTrials.gov registry entry for NCT06515990 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Doma Biopharmaceutical(Suzhou)Co., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Carcinoma, Non-Small-Cell Lung appearing as the primary indexed condition, and to 1 intervention — of which DM005 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06515990 reports 6 study locations spanning 5 distinct geographic areas — top geographies include New South Wales, Michigan, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06515990 about?

NCT06515990 is a clinical study titled "A Study of DM005 in Patients With Advanced Solid Tumors". 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 ...

What is the current status of trial NCT06515990?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2024-10-31. Estimated completion is 2027-03.

What conditions does trial NCT06515990 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Solid Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06515990?

The interventions under investigation include: DM005 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06515990?

This trial is sponsored by Doma Biopharmaceutical(Suzhou)Co., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06515990 being conducted?

This trial has 6 study locations across Michigan, Texas, Virginia, New South Wales, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial