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New pill targets Hard-to-Treat cancers in early trial

NCT ID NCT06305247

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 6 times

Summary

This study tests a new oral drug called IPN01194 in 36 adults with advanced solid tumours (melanoma, colorectal, pancreatic, or head and neck cancer) that have not responded to standard treatments. The goal is to find the right dose and check if it is safe, while also looking for signs that it can shrink tumours. All participants take the drug by mouth in 28-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
IPN01194 (an ERK1/2 inhibitor taken orally)
What this could lead to
If successful, this could point toward a new treatment option for certain advanced solid tumours that have not responded to other therapies.
What could go wrong
This is an early, small trial (36 participants) focused on safety and dosing. The drug may not shrink tumours or could cause side effects. It is too soon to know if it will work.

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

36 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Mar 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.

Inclusion Criteria : * Participants must be ≥18 years of age * Participants with histologically confirmed metastatic solid tumour (melanoma, metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head and neck squamous cell carcinoma (HNSCC)) for whom no suitable alternative standard therapy exists. * Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm). * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 * Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1. * Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening * Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. Exclusion Criteria * Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications. * Any evidence of severe active infection or inflammatory condition. * Non-adequate cardiac function * Have one or more of study defined ophthalmological findings/conditions * Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant's ability to cooperate with the requirements of the study. * Underlying medical conditions that, in the investigator's or sponsor's opinion, will obscure the interpretation of toxicity determination or AEs. * Known second malignancy within the last 2 years prior to first dose of study intervention.. * Major surgery within 28 days prior to first dose of study intervention. * Ongoing AEs caused by any prior anti-cancer therapy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0). * Active brain metastases or leptomeningeal metastases * Current enrolment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days. * Live vaccine(s) within 28 days prior to first dose of study intervention * Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents). * Treatment with medications that prolong the QT/QTc interval. * Treatment with strong and moderate CYP3A4 inducers * Treatment with strong or moderate inhibitors of CYP3A4 * Only for Phase I participants assigned to dose escalation and low-dose backfill participants: treatment with proton pump inhibitors within 14 days prior to first dose of study intervention. * Non-adequate bone marrow function * Non-adequate renal function * Non-adequate hepatic function * Non adequate coagulation function. * Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C * Sensitivity to IPN01194 or any of its components.

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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

  • Barcelona - Val D'Hebron

    Barcelona, Spain

  • Centre Léon Bérard - Lyon

    Lyon, France

  • Fundacion Jimenez Diaz - Madrid

    Madrid, Spain

  • IGR-Villejuif

    Villejuif, France

  • Institut de Cancerologie de l'Ouest (St-Herblain)

    Saint-Herblain, France

  • M.D. Anderson Cancer Center Madrid

    Madrid, Spain

  • Paris Saint-Louis

    Paris, France

  • Sarah Cannon Research Institute (SCRI) - Nashville

    Nashville, Tennessee, 37203, United States

  • The Angeles Clinic and Research Institute - California

    Los Angeles, California, 90025, United States

  • Virginia Cancer Specialist

    Fairfax, Virginia, 22031, United States

  • Yale Cancer Center - New Heaven

    New Haven, Connecticut, 06510, United States

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Other studies related to the condition(s) this trial covers.