deltatrials
Recruiting INTERVENTIONAL NCT06305247

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 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

Sponsor: Ipsen

Updated 17 times since 2024 Last updated: Apr 29, 2026 Started: Apr 3, 2024 Primary completion: Mar 20, 2028 Completion: Mar 20, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Colorectal Cancer and Head and Neck Squamous Cell Carcinoma and is currently actively recruiting participants. Ipsen leads this study, which shows 17 recorded versions since 2024 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

The study consists of two parts, called Phase I and Phase IIa. Phase I is designed to assess the safety of increasing doses of IPN01194 in participants with specific types of advanced solid tumours. The aim of this "dose escalation" phase is to find the dose range showing activity on the tumor that can be tolerated by the participants, and to determine the two doses for further testing in Phase IIa. Phase I will assess how the body processes and responds to the study drug when administered with and without food. In Phase IIa, participants with selected single tumour type will be invited to take part. During this phase, the two dose levels of the study drug identified from Phase I will be tested. Participants will take the study drug one of the two dose levels. Each participant will be assigned to a dose level at random (by chance). Each phase will consist of three periods: 1. A period to assess eligibility (screening period) that will take up to 28 days. 2. A treatment period of at least 28 days that will require at least two visits for the first month followed by one visit every month. There will be...

The study consists of two parts, called Phase I and Phase IIa.

Phase I is designed to assess the safety of increasing doses of IPN01194 in participants with specific types of advanced solid tumours.

The aim of this "dose escalation" phase is to find the dose range showing activity on the tumor that can be tolerated by the participants, and to determine the two doses for further testing in Phase IIa. Phase I will assess how the body processes and responds to the study drug when administered with and without food.

In Phase IIa, participants with selected single tumour type will be invited to take part. During this phase, the two dose levels of the study drug identified from Phase I will be tested. Participants will take the study drug one of the two dose levels. Each participant will be assigned to a dose level at random (by chance).

Each phase will consist of three periods:

1. A period to assess eligibility (screening period) that will take up to 28 days. 2. A treatment period of at least 28 days that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at least 30 days after the last administration of study drug. 3. A follow-up period (Phase IIa participants only), where every 3 months, participants will be contacted by phone, until death or the study cut-off date, whichever comes first.

Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded.

If in the opinion of the investigator a participant is continuing to experience clinical benefit after the cut-off date, the participant may remain in the study and continue to receive the study drug until either disease progression, unacceptable toxicity or other withdrawal criteria are met.

Status Flow

~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Dec 2024 · 2 months · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Mar 2025 · 59 days · monthly snapshot~Mar 2025 – ~May 2025 · 2 months · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Dec 2025 · 2 months · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~May 2026 · 3 months · monthly snapshotRecruitingMay 4, 2026 – present · 58 days · daily API

Change History

17 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: PHASE1/PHASE2None

  2. Feb 2026 — May 2026 [monthly]

    Recruiting PHASE1/PHASE2

  3. Jan 2026 — Feb 2026 [monthly]

    Recruiting PHASE1/PHASE2

  4. Dec 2025 — Jan 2026 [monthly]

    Recruiting PHASE1/PHASE2

  5. Oct 2025 — Dec 2025 [monthly]

    Recruiting PHASE1/PHASE2

Show 12 earlier versions
  1. Sep 2025 — Oct 2025 [monthly]

    Recruiting PHASE1/PHASE2

  2. Jul 2025 — Sep 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Jun 2025 — Jul 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. May 2025 — Jun 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Mar 2025 — May 2025 [monthly]

    Recruiting PHASE1/PHASE2

  6. Jan 2025 — Mar 2025 [monthly]

    Recruiting PHASE1/PHASE2

  7. Dec 2024 — Jan 2025 [monthly]

    Recruiting PHASE1/PHASE2

  8. Oct 2024 — Dec 2024 [monthly]

    Recruiting PHASE1/PHASE2

  9. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE1/PHASE2

  10. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  11. May 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  12. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

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. The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body. In this study, all participants will receive the study drug, which will be taken by mouth (orally).

Contact Information

Sponsor contact:
  • Ipsen
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .