IPN01194 for Cancer

Recruiting at 10 trial locations

Overseen By Ipsen Clinical Study Enquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ipsen

Must not be taking: QT prolongers, CYP3A4 modulators

Disqualifiers: Infections, Cardiac issues, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose and assess the safety and effectiveness of a new drug, IPN01194, for individuals with advanced solid tumors (cancers that have spread within the body). Participants will take the drug orally, and the study will explore various doses to identify the most effective one. The trial seeks adults with specific cancers, such as melanoma or pancreatic cancer, who have certain genetic changes and lack other treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires stopping certain medications, such as those that prolong the QT/QTc interval and strong or moderate CYP3A4 inducers or inhibitors. If you are taking these, you may need to stop them before joining the trial.

Is there any evidence suggesting that IPN01194 is likely to be safe for humans?

Research has shown that IPN01194 is still under study to ensure its safety for humans. So far, human trials have provided limited information. In these early stages, the trial primarily aims to determine the correct dosage and identify any side effects. Researchers are testing the drug to assess its tolerability. The available information has not reported any serious side effects, but a complete understanding remains premature. As testing continues, more safety information will emerge. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Unlike the standard cancer treatments that primarily rely on chemotherapy, radiation, or immunotherapy, IPN01194 is unique because it targets cancer through a novel mechanism of action. Researchers are excited about IPN01194 because it potentially offers a more precise approach to attacking cancer cells, minimizing damage to healthy cells, which could reduce side effects often seen with traditional treatments. This innovative approach might lead to more effective control of the disease with fewer complications, making it a promising option for patients.

What evidence suggests that IPN01194 might be an effective treatment for advanced solid tumours?

Research has shown that IPN01194 is being tested for its potential to treat advanced solid tumors. The trial includes a Phase I arm, focusing on dose escalation with backfilling to determine the optimal dose, and a Phase IIa arm, involving cohort expansion to further evaluate the drug at selected doses. No public results have yet been released regarding its effectiveness in people. The drug aims to inhibit cancer cell growth, which is why researchers believe it might be effective. Early studies focus on identifying the right dose and understanding the drug's mechanism in the body. Although still under investigation, the hope is that it can help slow or stop tumor growth. ^{1 5 6 7 8}

Who Is on the Research Team?

Ipsen Medical Director

Principal Investigator

Ipsen

Are You a Good Fit for This Trial?

Adults over 18 with advanced solid tumors like melanoma, colorectal cancer, pancreatic cancer, or head and neck squamous cell carcinoma can join. They must have specific genetic mutations (MAPKm), measurable disease by RECIST criteria, and be in good physical condition (ECOG/PS of 0 or 1). No other effective standard treatments should be available for them.

Inclusion Criteria

Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1

I am using birth control as required by local laws for clinical trial participants.

I am fully active or can carry out light work.

Exclusion Criteria

My heart isn't working well.

I have specific eye conditions identified for the study.

Current enrollment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Phase I

Dose escalation to assess safety and determine dose range for Phase IIa

At least 4 weeks

At least 2 visits in the first month, then monthly visits

Treatment Phase IIa

Cohort expansion to test two dose levels identified in Phase I

Up to approximately 32 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months until death or study cut-off

Contacted by phone

What Are the Treatments Tested in This Trial?

Interventions

• IPN01194

Trial Overview The trial is testing IPN01194's correct dosage, safety, and effectiveness when taken orally by adults with advanced solid tumors. All participants will receive the study drug to see how well it works against their cancers.

How Is the Trial Designed?

Group I: Phase IIa (Cohort Expansion) Experimental Treatment 1 Intervention

Study intervention will be administered at one of two doses of interest determined at the end of Phase I.

Group II: Phase I (Dose Escalation with Backfilling) Experimental Treatment 1 Intervention

Nine dose levels are planned to be tested.

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06305247

NCT06305247 | A Study to Assess IPN01194 When ... The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.

2. clinicaltrials.eu clinicaltrials.eu/inn/ipn01194/

Ipn01194 – Application in Therapy and Current Clinical ... IPN01194 is a new drug currently being studied for its potential to treat various types of advanced solid tumors.

3. yalemedicine.org yalemedicine.org/clinical-trials/a-study-to-assess-ipn01194-when-administered-alone-in-adults-with-advanced-solid-tumours

An Open-label, Phase I/IIa First-in-human, Dose Escalation ... The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced

4. healthscout.app healthscout.app/trial_match/view_trial/NCT06305247/?back=/trial_match/view_trials/condition/skin_scc/%3Fpage%3D6

Trial: A Study to Assess IPN01194 When Adminis… - HealthScout Efficacy. As of October 7, 2025, no human efficacy results for IPN01194 have been publicly reported. The Phase IIa portion lists progression‑free survival ...

5. synapse.patsnap.com synapse.patsnap.com/drug/9c5b5702fe9d45fa9a320e179d924765

IPN-01194 - Drug Targets, Indications, Patents An open-label, Phase I/IIa first-in-human, dose escalation and cohort expansion study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic ...

6. ipsen.com ipsen.com/update/esmo-2025-new-data-reinforces-breadth-and-depth-of-ipsens-growing-oncology-pipeline-and-portfolio-3165272/

ESMO 2025: new data reinforces breadth and depth of ... In 2024, the IPN01194 progressed into Phase I/IIa clinical trials in people living with metastatic melanoma, colorectal cancer, pancreatic ...

7. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/CLIN-01194-450

IPN01194 as Single Agent in Advanced Solid Tumors Researchers will evaluate the safety, tolerability and anti-tumor activity of IPN01194. The study will also examine the pharmacodynamics (what the study ...

8. trials.braintumor.org trials.braintumor.org/trials/NCT06305247

A Study to Assess IPN01194 When Administered Alone in ... The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.