RecruitingPhase 1NCT06751329

A Study of DM002 in Patients With Advanced Solid Tumors

A Phase I, Multicentre, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors


Sponsor

Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

Enrollment

160 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of study: The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you. The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers. In Part 2, participants will receive the best dose level that was determined in Part 1 of the study. The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug. Participants will: Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called DM002 in people with advanced solid tumors (cancers that have not responded to standard treatments). The study is in early phases, aiming to find a safe and effective dose and to see which tumor types might benefit most from this treatment. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor (any type) that has not responded to standard treatments - You are in reasonably good general health (ECOG performance status 0–2) - Your expected survival is at least 3 months - Your blood counts, liver function, and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your general health is too poor to tolerate treatment (ECOG status 3 or higher) - You have significant organ dysfunction - You are pregnant or breastfeeding - You have received prior treatments that could interfere with the study drug 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

DRUGDM002

An IV infusion of DM002 will be administrated approximately 30-60 min on D1 once Q3W


Locations(5)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Scientia Clinical Research

Randwick, New South Wales, Australia

Cancer Care Wollongong

Wollongong, New South Wales, Australia

Southern Oncology Clinical Research Unit

Adelaide, South Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT06751329


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