Can a targeted 'Missile' drug shrink Hard-to-Treat tumors?

NCT ID NCT07807241

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests an experimental drug called MX006 in people with advanced solid tumors that carry a specific marker, B7-H3. MX006 is designed to deliver a toxic payload directly to cancer cells while sparing healthy tissue. The study has two parts: first, to find the safest dose, and second, to see how well that dose works. Researchers will monitor side effects and measure whether tumors shrink or stop growing.

What this could mean

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

Active substance
MX006, an antibody-drug conjugate that targets a protein called B7-H3 found on tumor cells
What this could lead to
If MX006 proves safe and effective, it could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early, first-in-human trial, so the drug may not work as hoped or may cause serious side effects. The results will only show whether further testing is warranted.

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 120 people

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

Started

Jul 2026

Expected to finish

Jul 2030

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: * Male and female patients aged 18 years-or older at the time of signature of the informed consent form. * Patients with advanced/metastatic cancer, with measurable disease as determined by RECIST v1.1 or the Prostate Cancer Clinical Trials Working Group 3 (for mCRPC only) as per Investigator discretion. Note: Patients with mCRPC can be enrolled without measurable disease but must have a minimum of 2 bone lesions and increased PSA. * Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors in patients with relapsed or refractory solid tumors known to express B7-H3 who have failed available standard therapy or who are not candidates for standard therapy. * Has adequate bone marrow and organ function within 7 days before the start of study * Has an adequate treatment washout period prior to start of study treatment, defined as: * Major surgery: ≥4 weeks (or 2 weeks for low-invasive cases \[e.g., colostomy\]). Note: major surgery is defined for example as a surgical procedure that is complex, invasive (e.g., enters a body cavity), is associated with higher risk of complications, and may require general anesthesia and hospitalization. * Radiation therapy: ≥4 weeks (if palliative single site stereotactic radiation therapy, ≥2 weeks.) Exclusion Criteria: * Prior treatment with an NMT inhibitor or any antibody-drug conjugate (ADC) that delivers an NMTi payload. * Has other invasive malignancy within 2 years; prior or concurrent non-invasive malignancies (with the exception of the following: in situ carcinomas of the cervix, non-melanoma skin cancers) and/or patients with localized malignancies that were treated with curative intent (e.g., localized breast cancer) who remain disease-free and are considered low likelihood for recurrence who may be enrolled on a case-by-case basis after discussion with the Medical Monitor). * Have clinically significant cardiac disease, known congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment, and/ or a known decreased cardiac ejection fraction of \< 45%. A baseline QT interval as corrected by Fridericia's formula (QTcF) \> 470 msec, a complete left bundle branch block (defined as a QRS interval ≥ 120 msec in left bundle branch block form) or an incomplete left bundle branch block based on the average of triplicate 12-lead electrocardiogram (ECG) per local read. * Received any of the following within the specified time frame prior to administration of study treatment: Any systemic agent from a previous treatment regimen or clinical study including anti-cancer chemotherapy or small molecule ≤14 days or 5 half-lives (whichever is shorter); any biologic or hormonal agent ≤28 days or 5 half-lives (whichever is shorter). * Received any of the following within the specified time frame prior to administration of study treatment: Platelet transfusion, red blood cell transfusion and/or granulocyte colony-stimulating factor administration \< 1 week prior to screening assessments. Other protocol defined Inclusion/Exclusion criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced and/or metastatic solid tumors known to express B7-H3 are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States