Recruiting
Phase 1
Phase 2

IPN01195

Sponsor:

Ipsen

Code:

NCT06833008

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IPN01195

Study Details

Brief summary:

The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 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.

Conditions

Advanced Solid Tumor

Study ID

NCT06833008

Start date

Mar 14, 2025

Status verified date

Aug, 2026

Completion date

Oct 3, 2028

Anticipated

Primary completion date

Oct 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must be ≥18 years of age or the country's legal age of majority if the legal age is more than 18 years at the time of signing the informed consent.
  • Participants with histologically confirmed metastatic solid tumour for whom no suitable alternative standard therapy exists.
  • Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.
  • Part A: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for central confirmation of mutation status.
  • Part B: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for MAPK genomic testing to confirm eligibility.
  • 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
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

  • Gastrointestinal conditions that could impair absorption of IPN01195 (specific cases e.g. remote history of gastrointestinal surgery, may be enrolled after discussion with the medical monitor)
  • Any evidence of severe active infection or inflammatory condition.
  • Non-adequate cardiac function
  • 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 either progressing or requiring active treatment within the last 2 years prior to first dose of the study intervention.
  • Active brain metastases or leptomeningeal
  • Current enrolment or past participation in any other clinical studies involving an investigational study treatment within the last 28 days
  • Live vaccine(s) within 28 days prior to first dose of the study intervention or plan to receive such vaccines during the study.
  • Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
  • Washout period of less than 28 days prior anti-cancer therapy (including chemotherapy, targeted agents, radiotherapy). If the participant was treated with an agent having a short half-life, washout can be <28 days but not shorter than 5 times the half-life.
  • Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of the study intervention.
  • Non-adequate bone marrow function
  • Non-adequate renal function
  • Non-adequate hepatic function
  • Known human immunodeficiency virus (HIV) infection. HIV testing will be performed in any countries where mandatory per local requirements.
  • Known uncontrolled or untreated hepatitis infection.

  • (a) Known uncontrolled hepatitis B virus (HBV) infection.
  • (b) Known untreated current hepatitis C virus (HCV) infection.
  • Sensitivity to IPN01195 or any of its components.

Study Design

Enrollment

85 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A (dose escalation)

IPN01195 will be administered at assigned dose level.

experimental: Part B - (randomisation)

Participants will be randomised to one of the two doses of interest once the PADR is determined

Interventions

IPN01195

IPN01195 will be administered at assigned dose level.

Primary outcome measure

  • Part A: Percentage of participants with dose limiting toxicity (DLT) [ Time Frame: Part A: within 28 days of first dose. ]
  • Part A and B: Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs). [ Time Frame: From the first IPN01195 administration to 30 days after last dose. ]
  • Part A and B: Percentage of participants with dose interruptions and permanent treatment discontinuations [ Time Frame: From the first study drug administration to 30 days after last dose. ]
  • Part B: Objective response rate (ORR) [ Time Frame: Part B: At end of study (up to approximately 3 years) ]

Central Contacts and Locations

Central contacts

Ipsen Clinical Study Enquiries

See emailclinical.trials@ipsen.com

Locations

START Mid-West

Recruiting

Grand Rapids, Michigan, United States, 49546

Sarah Cannon Research Institute (SCRI) - Nashville

Recruiting

Nashville, Tennessee, United States, 37203

Mary Crowley Cancer Research Centers - Medical City Hospital - Dallas

Recruiting

Dallas, Texas, United States, 75230

START Mountan Region

Recruiting

West Valley City, Utah, United States, 84119

Virginia Cancer Specialist- Fairfax

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Ipsen

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ipsen on 2026-09-01.