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New drug duo aims to reboot immune attack on Hard-to-Treat cancers

NCT ID NCT04457778

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-phase trial tested a new drug called M6223, which blocks a protein called TIGIT that can turn off immune cells. M6223 was given alone or together with another drug, bintrafusp alfa, to 58 people with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety, find the right dose, and see if the combination could help control the cancer.

What this could mean

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

Active substance
M6223 (a drug that blocks TIGIT, a protein on immune cells) and bintrafusp alfa (a drug that targets PD-L1 and TGF-beta)
What this could lead to
If this works, it could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 58 participants, so it is primarily checking safety and dosing. The drugs may not shrink tumors or may cause significant side effects.

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

58 people

The number who actually took part.

Started

Jul 2020

Finished

Jun 2023

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: * Participants have histologically or cytologically proven locally advanced or advanced solid malignancies who are refractory to or have progressed under standard treatment and have no other treatment options known to confer clinical benefit * Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at Screening * Participant has a formalin-fixed paraffin-embedded block containing tumor tissue or a minimum of 15 (preferably 25) unstained tumor slides suitable for immunohistochemistry-based staining of protein expression * Participants with life expectancy of at least 12 weeks * Participants with measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) * Adequate hematological, hepatic and renal function as defined in the protocol * Other protocol defined inclusion criteria may apply Exclusion Criteria: * Participants with persisting toxicity related to prior therapy Grade greater than (\>) 1 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, however, alopecia, sensory neuropathy Grade less than or equal to (\<=) 2, or other non-immune-related Grade \<= 2 not constituting a safety risk * Participants with prior organ transplantation including allogeneic stem cell transplantation * Participants with prior toxicity related to an immune checkpoint inhibitor Grade greater than equal to (\>=) 3 NCI-CTCAE Version 5.0 unless resolved to Grade \<= 1 prior to study inclusion * Participants with current significant cardiac conduction abnormalities, including corrected QT interval (QTcF, corrected with Fridericia formula) prolongation of \> 450 milli seconds (ms) on triplicate 12-lead ECG or impaired cardiovascular function, ventricular tachycardia, hypokalemia or a history of paroxysmal atrial fibrillation, serious cardiac arrhythmia and family history of sudden death or long QT syndrome * A history of vascular, cardiovascular or cerebrovascular disease like, cerebral vascular accident/stroke (less than \[\<\] 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class \>= II), deep vein thrombosis (\< 3 months prior to enrollment) or pulmonary thrombosis/embolism (\< 3 months prior to enrollment) * Other protocol defined exclusion criteria may apply

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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

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Next Oncology

    San Antonio, Texas, 78229, United States

  • Princess Margaret Cancer Centre

    Toronto, Canada

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

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