RecruitingPhase 1NCT06515990

A Study of DM005 in Patients With Advanced Solid Tumors

A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors


Sponsor

Doma Biopharmaceutical(Suzhou)Co., Ltd.

Enrollment

136 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called DM005 in people with advanced non-small cell lung cancer (NSCLC) or advanced gastroesophageal (stomach and food pipe) cancer. The drug targets specific proteins — EGFR and HER2 — found on some cancer cells. The study aims to find the safest effective dose and see how well the drug works. **You may be eligible if...** - You have a confirmed diagnosis of metastatic or advanced non-small cell lung cancer (NSCLC) or gastroesophageal cancer - Your cancer has specific genetic features: EGFR or HER2 mutations or amplification (your doctor can test for these) - You are willing and able to provide written consent **You may NOT be eligible if...** - Your cancer does not have the relevant EGFR or HER2 genetic features - You have other serious medical conditions that would make study participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDM005

An IV infusion of DM005 will be administrated approximately 30-60 min on D1 once Q3W.


Locations(6)

Henry Ford Cancer Institute

Detroit, Michigan, United States

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Macquarie University Hospital

North Ryde, New South Wales, Australia

ICON Cancer Center

South Brisbane, Queensland, Australia

View Full Details on ClinicalTrials.gov

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NCT06515990


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