RecruitingPhase 1NCT06475937

A Study of DM001 in Patients With Advanced Solid Tumors

A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors

Sponsor

Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

Enrollment

128 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms

Summary

The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. Participants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called DM001 in people with advanced solid tumors — including breast cancer, non-small cell lung cancer, gastric (stomach) cancer, or colorectal cancer — that has stopped responding to standard treatments. The goal is to find out if DM001 is safe and whether it can shrink tumors. **You may be eligible if...** - You are 18 years old or older - You have been confirmed with advanced or metastatic breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, or colorectal cancer - Your cancer has progressed after standard treatment or no standard treatment is available - You are generally in good health (ECOG 0 or 1) - You have at least one measurable area of cancer **You may NOT be eligible if...** - You have had another active cancer in the past 5 years - You have uncontrolled brain metastases - You have an uncontrolled infection, severe cardiovascular disease, or active liver disease - You are HIV positive, have active Hepatitis B or C - You are pregnant or breastfeeding 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

DRUGDM001

Subjects may continue to receive DM001 (with an increased dose that has been assessed as safe in the dose-escalation period) once every 3 weeks (Q3W) for a total of 6 cycles at the discretion of the investigators, until unacceptable toxicity, progressive disease (PD), or withdrawal of consent.