Can a daily pill target cancers driven by the MYC gene?

NCT ID NCT07864701

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 08, 2026 · Last updated Oct 16, 2026 · Updated 3 times

Summary

Researchers are testing an experimental oral tablet called JMBI-001 in adults with advanced solid tumors or relapsed non-Hodgkin lymphoma that carry a MYC gene abnormality. The trial aims to find a safe dose, measure how the body processes the drug, and see whether tumors respond. Participants take the tablet once daily for four days followed by three days off, in repeating 21-day cycles.

What this could mean

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

Active substance
an experimental oral tablet called JMBI-001
What this could lead to
If it works, this could point toward an oral treatment for cancers driven by the MYC gene, which currently have few targeted options.
What could go wrong
This is an early-phase trial, so researchers mainly test safety and dosing. The drug may not shrink tumors, and participants may experience side effects that limit treatment.

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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 150 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 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 to 75 years

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: * Able to fully understand the study requirements, voluntarily agree to participate in the study, and provide written informed consent. * Male or female participants aged 18 to 75 years, inclusive. * Histologically or cytologically confirmed malignant tumor. Participants with solid tumors must have unresectable locally advanced or metastatic disease for which standard treatment has failed, is not tolerated, or is unavailable. Participants with non-Hodgkin lymphoma must have received at least two prior lines of therapy. Tumor-specific requirements for each study phase are as follows: 1. Phase Ia dose-escalation stage: Solid tumors, including but not limited to gastric cancer, colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and triple-negative breast cancer. Non-Hodgkin lymphoma, including but not limited to diffuse large B-cell lymphoma and Burkitt lymphoma. 2. Phase Ib dose-expansion stage: tumor indications within prespecified tumor types of particular interest, potentially sensitive tumor types or subtypes identified during Phase Ia, or both. Prespecified tumor types of particular interest include, but are not limited to, gastric cancer, colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and non-Hodgkin lymphoma. 3. Phase II indication-expansion stage: selected tumor indications that meet the prespecified transition criteria during Phase Ib. * Except for participants enrolled in the accelerated titration stage of Phase Ia, tumor tissue obtained or submitted during screening must be tested by immunohistochemistry and meet the following criteria for MYC positivity: 1. Solid tumors: MYC-positive tumor cell nuclei in at least 10% of tumor cells. 2. Non-Hodgkin lymphoma: MYC-positive tumor cell nuclei in at least 40% of tumor cells. * At least one lesion suitable for efficacy assessment, as follows: 1. For participants with solid tumors, at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). The longest diameter must be at least 10 mm on spiral computed tomography, or the short-axis diameter of an enlarged lymph node must be at least 15 mm. A lesion selected as a target lesion must not have received radiotherapy within 4 weeks before the first dose of JMBI-001; palliative local radiotherapy to a non-target lesion is permitted. 2. For participants with non-Hodgkin lymphoma, according to the Lugano 2014 criteria, the longest diameter must be greater than 1.5 cm for a nodal lesion or greater than 1.0 cm for an extranodal lesion. Exclusion Criteria: * Difficulty swallowing or inability to swallow tablets. * Known hypersensitivity to any component of JMBI-001 tablets. * Carcinomatous meningitis, brainstem metastasis, or spinal cord compression confirmed by imaging or clinical diagnosis. * History of a severe neurologic disorder or severe psychiatric or psychological disorder that may interfere with the participant's ability to understand or comply with the study protocol. * Systemic glucocorticoid therapy within 2 weeks before the first dose of JMBI-001 at a prednisone-equivalent dose greater than 10 mg/day. * Gastrointestinal disease or abnormality that may affect the absorption of JMBI-001, including but not limited to celiac disease, short bowel syndrome, Crohn disease, ulcerative colitis, gastrointestinal perforation, or severe vomiting or diarrhea. Other Inclusion/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.

How to take part

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

  1. The places running it

    1 site. 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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Peking University Cancer Hospital & Institute

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

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