New pill targets Hard-to-Treat cancers in early trial
NCT ID NCT06305247
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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36 people
The number who actually took part.
- Started
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Apr 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Barcelona - Val D'Hebron
Barcelona, Spain
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Centre Léon Bérard - Lyon
Lyon, France
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Fundacion Jimenez Diaz - Madrid
Madrid, Spain
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IGR-Villejuif
Villejuif, France
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Institut de Cancerologie de l'Ouest (St-Herblain)
Saint-Herblain, France
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M.D. Anderson Cancer Center Madrid
Madrid, Spain
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Paris Saint-Louis
Paris, France
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Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee, 37203, United States
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The Angeles Clinic and Research Institute - California
Los Angeles, California, 90025, United States
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Virginia Cancer Specialist
Fairfax, Virginia, 22031, United States
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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.
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- Can immunotherapy before surgery stop early oral cancer from returning?
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors