Can a new drug DM001 take on advanced solid tumors?

NCT ID NCT06475937

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This early-stage trial tests an experimental drug called DM001 in people with advanced solid tumors, including breast cancer, non-small cell lung cancer, and other solid cancers that have progressed on standard treatment. The main goals are to find a safe dose, identify side effects, and see how the body processes the drug. Participants receive DM001 every three weeks for up to six cycles, with regular check-ups to monitor safety and any signs of anti-tumor activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DM001, an experimental drug given by intravenous infusion every three weeks
What this could lead to
If DM001 proves safe and shows anti-tumor activity, it could become a new treatment option for people with advanced breast cancer, lung cancer, or other solid tumors that have stopped responding to standard therapy.
What could go wrong
This is a first-in-human Phase 1 trial, so the main goals are safety and finding the right dose. DM001 may cause serious side effects, and it is too early to know if it will shrink tumors or improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects must have the ability to understand and willingness to sign a written informed consent document. 2. Subjects 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, or intolerant to standard therapy, or no standard therapy accessible to the subjects due to any reason. 3. Subjects must be ≥18 years of age at the time of signing the informed consent form. 4. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Has a life expectancy of ≥3 months. 6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Exclusion Criteria: 1. Subjects have another active invasive malignancy within 5 years. 2. Current or history of a hematologic malignancy. 3. 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 equivalent) for at least 4 weeks. 4. Individuals with Gilbert's disease with ≥3 × ULN. 5. Has an uncontrolled infection requiring intravenous (IV) injection of antibiotics, antivirals, or antifungals. 6. Has a medical history of clinically significant lung diseases or is suspected to have these diseases by imaging at the screening period. 7. Clinically uncontrolled intercurrent illness, including but not limit to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies. 8. 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; no family history of long QT syndrome. 9. 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 DNA) who receive prophylactic treatment during the study can be enrolled. Subjects with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV RNA negative due to prior treatment or natural resolution should be eligible. 10. Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate. 11. Subjects 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 participate in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland, 4101, Australia

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Sarah Cannon Research Institute (SCRI)

    Nashville, Tennessee, 37203, United States

  • Tasman Oncology Research

    Southport, Queensland, 4215, Australia

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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