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NCT06515990 · ClinicalTrials.gov registry record · Phase 1

A Study of DM005 in Patients With Advanced Solid Tumors

A Phase 1 study of Carcinoma, Non-Small Cell Lung and Squamous Cell Carcinoma of Head and Neck, sponsored by Doma Biopharmaceutical（Suzhou）Co..

Recruiting
Registry status
Phase 1
Development phase
136
Enrollment target
6
Study locations

NCT06515990 is a Phase 1 study of Carcinoma, Non-Small Cell Lung and Squamous Cell Carcinoma of Head and Neck that is actively recruiting participants, run by Doma Biopharmaceutical（Suzhou）Co.. The registered enrollment target is 136 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (58% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT06515990, a Phase 1 study of Carcinoma, Non-Small Cell Lung and Squamous Cell Carcinoma of Head and Neck, is actively recruiting participants, sponsored by Doma Biopharmaceutical（Suzhou）Co..

RECRUITING
Registry status
Phase 1
Development phase
136 participants
Enrollment target
6
Study locations

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.

Conditions Studied

Carcinoma, Non-Small Cell Lung Squamous Cell Carcinoma of Head and Neck Solid Carcinoma

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

Sponsor

Doma Biopharmaceutical（Suzhou）Co.

1 total trials

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What the Registry Record Tells You About NCT06515990

The ClinicalTrials.gov registry entry for NCT06515990 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (58% lower). The listed sponsor is Doma Biopharmaceutical（Suzhou）Co., which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT06515990 reports 6 study locations spanning 5 distinct geographic areas - top geographies include New South Wales, Michigan, Texas.

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.

What interventions are being tested in trial NCT06515990?

The interventions under investigation include: DM005 (DRUG).

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.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.