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Assessing IPN01194 for advanced solid tumors in adults

An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours

Phase1; Phase2 Interventional Ipsen · NCT06305247

This study is testing a new drug called IPN01194 to see if it is safe and effective for adults with advanced solid tumors like melanoma and pancreatic cancer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years and up
SexAll
SponsorIpsen Industry-sponsored
Locations12 sites (Los Angeles, California and 11 other locations)
Trial IDNCT06305247 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, dosage, and effectiveness of the drug IPN01194 in adults with advanced solid tumors, including melanoma and pancreatic cancer. It consists of two phases: Phase I focuses on determining the maximum tolerated dose through a dose escalation approach, while Phase IIa tests the identified doses in participants with specific tumor types. Participants will receive the drug orally and undergo regular monitoring through blood tests and physical examinations. The study aims to provide insights into how the drug interacts with the body and its potential therapeutic effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic solid tumors and specific genetic mutations.

Not a fit: Patients with gastrointestinal conditions that could interfere with drug absorption may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies have shown promise with similar drug approaches, but this specific drug and its application in these tumor types are relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Los Angeles, California and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MelanomaHead and Neck Squamous Cell CarcinomaPancreatic Ductal AdenocarcinomaColorectal CancerSolid Tumor
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.