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New antibody aims to supercharge immune system against cancer

NCT ID NCT07610941

Disease control Sponsor: Mestag Therapeutics Limited Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called MST-0312, designed to help the body's immune system fight cancer more effectively. It is being studied alone or with another cancer drug (pembrolizumab) in people with several types of solid tumors, including lung, melanoma, bladder, colorectal, and triple-negative breast cancer. The main goals are to check safety, find the right dose, and see if it shrinks tumors. This is the first time MST-0312 is given to humans.

What this could mean

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

Active substance
MST-0312 (a bispecific antibody that stimulates the immune system to fight cancer)
What this could lead to
If successful, this could lead to a new treatment option for certain cancers like lung, melanoma, bladder, colorectal, and triple-negative breast cancer.
What could go wrong
This is a very early Phase 1 trial, the first time MST-0312 is tested in humans. It primarily checks safety and dosing, so it may not show strong anti-cancer effects. Side effects are unknown and could be significant.

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 157 people

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

Started

Apr 2026

Expected to finish

Dec 2029

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 subjects of any ethnic origin, aged 18 years and over. * Must have given written informed consent and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. * Subject must have a solid malignancy (non-small cell lung cancer (NSCLC), melanoma, bladder cancer, colorectal cancer (CRC) and triple negative breast cancer (TNBC)). * An ECOG performance status of 0 or 1 with no deterioration over the previous two weeks. * Willing to permit access to stored historical tumour tissue and prior tumour radiological assessments, cancer treatment history, including response to treatment, and tumour biomarker data, where available. * Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other trial procedures. Exclusion Criteria: * Any unresolved toxicity (except alopecia) from prior therapy of ≥2 CTCAE Grade. * Active or documented history of autoimmune disease requiring interventional therapy. * Active infection requiring systemic antibiotic, antifungal, or antiviral medication within 14 days prior to first dose of IMP. * Male or female subjects of childbearing potential unwilling to comply with contraception requirements.

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Conditions

The condition(s) this trial relates to.

cancer colorectal cancer melanoma neoplasm non-small cell lung carcinoma triple-negative breast carcinoma urinary bladder carcinoma

As listed by the trial registrant

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

Cancer-neoplasms

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clinica Universidad De Navarra

    NOT_YET_RECRUITING

    Madrid, 28027, Spain

  • Hospital Clinico Universitario De Valencia

    NOT_YET_RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 De Octubre

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Hm Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

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