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New drug combo targets Hard-to-Treat cancers in early trial

NCT ID NCT06975293

Disease control Sponsor: STORM Therapeutics LTD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 5 times

Summary

This early-phase trial tests a new drug called STC-15, either alone or combined with an immunotherapy drug (toripalimab), in people with advanced solid tumors or certain sarcomas. The study aims to check safety and whether the drugs shrink tumors. About 107 participants will be enrolled at multiple centers.

What this could mean

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

Active substance
STC-15 (a METTL3 inhibitor) and toripalimab (an immunotherapy drug)
What this could lead to
If successful, this could point toward a new treatment option for advanced cancers and sarcomas that have stopped responding to other therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects are possible, and the combination therapy may not work better than existing treatments.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 107 people

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

Started

May 2025

Expected to finish

Jun 2028

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.

Key Inclusion Criteria: * Estimated life expectancy ≥ 3 months. * ECOG performance status 0 or 1. * Measurable disease according to RECIST v1.1 as assessed by the local site investigator/radiology. * Documented radiologic assessment of progression on the prior therapy before study entry. * Have adequate organ function. * Have the ability to swallow, retain, and absorb oral medication. Inclusion Criteria (Phase 2 Monotherapy Cohorts): * Have histologic or cytologic confirmation of advanced sarcoma of the selected histologic subtype that is not amenable to local curative therapy. Participant must have received at least 2, but no more than 4 prior lines of systemic therapy. * Pre-treatment and on-treatment biopsy if medically feasible. Key Exclusion Criteria: * Pregnant and lactating women. * Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to first IMP administration. * Participants who have not recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline, according to NCI-CTCAE v5.0. Exceptions include: alopecia, Grade ≤ 2 neuropathy, and endocrine-related AEs Grade ≤ 2 who are stable on treatment or hormone replacement. * History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or the presence of ongoing pneumonitis/interstitial lung disease). * Clinically significant cardiovascular disease or condition. * Known active CNS metastases and/or leptomeningeal disease.

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Conditions

The condition(s) this trial relates to.

dedifferentiated liposarcoma endometrial cancer endometrial carcinoma head and neck squamous cell carcinoma leiomyosarcoma liposarcoma metastatic melanoma metastatic squamous cell carcinoma neoplasm non-small cell lung carcinoma sarcoma

As listed by the trial registrant

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

Dedifferentiated liposarcoma Leiomyosarcoma Metastatic endometrial cancer Metastatic head and neck squamous cell carcinoma Metastatic melanoma Metastatic non-small cell lung cancer Sarcoma Solid tumor

How to take part

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

  1. The places running it

    10 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

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Oncology

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Northwell Health Cancer Institute

    RECRUITING

    Lake Success, New York, 11042, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • The START Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

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