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New pill targets rare cancer mutation in early trial

NCT ID NCT06386146

Disease control Sponsor: Jacobio Pharmaceuticals Co., 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental oral drug, JAB-30355, in adults with advanced solid tumors that have a specific change in the TP53 gene (called Y220C). The trial aims to find a safe dose and see if the drug can shrink tumors. About 144 participants who have already tried at least one other cancer treatment will take part.

What this could mean

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

Active substance
JAB-30355 (oral drug targeting TP53 Y220C mutation)
What this could lead to
If successful, this could lead to a new targeted treatment option for people with advanced solid tumors that have a specific TP53 mutation.
What could go wrong
This is an early-phase trial (Phase 1/2a) with only 144 participants, so safety and effectiveness are not yet proven. The drug may not shrink tumors or could cause significant side effects.
Why investors are watching

Jacobio Pharmaceuticals is testing JAB-30355, an experimental drug for advanced solid tumors with a specific TP53 Y220C mutation, in a phase 1/2a trial with 144 participants. For a small company, this early data on safety and tumor response is a major value driver, as it is the main product in their pipeline.

If it works: If the trial shows the drug is safe and shrinks tumors, Jacobio could attract a larger partner or advance the drug to later-stage testing, which would validate its core asset.

If it fails: Most early-stage cancer drugs fail safety or efficacy tests, and a poor result or delay could leave Jacobio without a lead program, hurting its prospects. The trial is open-label and small, so even positive early signals may not hold up in larger studies.

AI-written from the trial record. Speculative, and not investment advice.

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 144 people

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

Started

Jul 2024

Expected to finish

Jul 2027

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: * Written informed consent. * Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF). * ECOG performance status score of 0 or 1. * Has been treated with at least one line of systemic therapy for that tumor type and stage. * Have documentation of confirmed TP53 Y220C mutation. * At least 1 measurable lesion per RECIST v1.1. * Adequate hematological, renal and hepatic function and appropriate coagulation condition. * Able to swallow and retain orally administered medication. Exclusion Criteria: * Active brain or spinal metastases or primary CNS tumor. * Active infection requiring systemic treatment within 7 days. * Active HBV or HCV. * Any severe and/or uncontrolled medical conditions. * LVEF ≤50% assessed by ECHO or MUGA. * QTcF \> 470 msec.

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Conditions

The condition(s) this trial relates to.

ovarian cancer

As listed by the trial registrant

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

Solid tumors

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

    13 sites in 2 countries. 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

  • Research Site

    RECRUITING

    Denver, Colorado, 80218, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

  • Research Site

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Research Site

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Research Site

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Research Site

    RECRUITING

    Zhengzhou, Henan, 451191, China

  • Research Site

    RECRUITING

    Shenyang, Liaoning, 110801, China

  • Research Site

    RECRUITING

    Jinan, Shandong, 250117, China

  • Research Site

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Research site

    TERMINATED

    Lake Mary, Florida, 32771, United States

  • Research site

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Research site

    TERMINATED

    Canton, Ohio, 44718, United States

  • Research site

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Research site

    RECRUITING

    Houston, Texas, 77030, United States

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