BridgeMD
New treatment option for Breast Neoplasms
Official title A Study of DM001 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06475937
What this study is testing
What is DM001?
DM001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must have the ability to understand and willingness to sign a written informed consent document.
- people who have pathologically or cytologically confirmed documented metastatic/advanced breast cancer, EGFRmut or EGFRwt NSCLC, gastric cancer...
- people must be ≥18 years of age at the time of signing the informed consent form.
- people must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of ≥3 months.
You likely can't join if
- people have another active invasive malignancy within 5 years.
- Current or history of a hematologic malignancy.
- Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated...
- Individuals with Gilbert's disease with ≥3 × ULN.
- Has an uncontrolled infection requiring intravenous (IV) injection of antibiotics, antivirals, or antifungals.
- Has a medical history of clinically significant lung diseases or is suspected to have these diseases by imaging at the screening period.
See the full eligibility criteria
- people must have the ability to understand and willingness to sign a written informed consent document.
- people who have pathologically or cytologically confirmed documented metastatic/advanced breast cancer, EGFRmut or EGFRwt NSCLC, gastric cancer, gastroesophageal cancer or CRC, and have progressed on standard therapy...
- people must be ≥18 years of age at the time of signing the informed consent form.
- people must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of ≥3 months.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- people have another active invasive malignancy within 5 years.
- Current or history of a hematologic malignancy.
- Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (\>20 mg prednisone or...
- Individuals with Gilbert's disease with ≥3 × ULN.
- Has an uncontrolled infection requiring intravenous (IV) injection of antibiotics, antivirals, or antifungals.
- Has a medical history of clinically significant lung diseases or is suspected to have these diseases by imaging at the screening period.
- Clinically uncontrolled intercurrent illness, including but not limit to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes...
- Mean resting corrected QT interval corrected by Fridericia's formula (QTcF, QTcF=QT/[RR]1/3) \>470 msec obtained from triplicate 12-lead ECGs at baseline; no concomitant medications that would prolong the QT internal...
- Known human immunodeficiency virus infection, or active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Chronic carriers of HBV infection (hepatitis B surface antigen-positive, undetectable, or low HBV...
- Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.
- people who are of reproductive potential refuse to use effective methods of birth control during the course of participation in the study and within 120 days for both women and men of the last dose are ineligible to...
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
- Houston, Texas, United States
- South Brisbane, Queensland, Australia
- Southport, Queensland, Australia
- Clayton, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States; Houston, Texas, United States; South Brisbane, Queensland, Australia; Southport, Queensland, Australia; Clayton, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.