A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours

NCT06833008 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CLIN-01195-450
• Study Type: interventional
• Target: 85
• Locations: 4 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (4)

• Part A: Percentage of participants with dose limiting toxicity (DLT)

  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).

  An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.

  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

  From the first study drug administration to 30 days after last dose.

• Part B: Objective response rate (ORR)

  Objective response rate is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator per RECIST version 1.1.

  Part B: At end of study (up to approximately 3 years)

Secondary Outcomes (12)

• Part A: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01195

  Cycle 1: at Day 1 and at Day 15.

• Part A: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01195

  Cycle 1: at Day 1 and at Day 15.

• Part A: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01195

  Cycle 1: at Day 1 and at Day 15.

• Part A: Geometric mean ratio of Cmax of IPN01195 administered in fed state relative to fasted state.

  Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)

• Part A: Geometric mean ratio of AUClast of IPN01195 administered in fed state relative to fasted state

  Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)

Study Arms (2)

Part A (dose escalation)

EXPERIMENTAL

IPN01195 will be administered at assigned dose level.

Drug: IPN01195

Part B - (randomisation)

EXPERIMENTAL

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

Drug: IPN01195

Interventions

IPN01195 DRUG

IPN01195 will be administered at assigned dose level.

Part A (dose escalation); Part B - (randomisation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (13)

START Mid-West

Grand Rapids, Michigan, 49546, United States

RECRUITING

Sarah Cannon Research Institute (SCRI) - Nashville

Nashville, Tennessee, 37203, United States

RECRUITING

Mary Crowley Cancer Research Centers - Medical City Hospital - Dallas

Dallas, Texas, 75230, United States

RECRUITING

START Mountan Region

West Valley City, Utah, 84119, United States

RECRUITING

Virginia Cancer Specialist- Fairfax

Fairfax, Virginia, 22031, United States

RECRUITING

Centre Léon Bérard - Lyon

Lyon, France

NOT YET RECRUITING

Paris Saint-Louis

Paris, France

RECRUITING

IGR-Villejuif

Villejuif, France

RECRUITING

Istituto Nazionale dei Tumori

Milan, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS - Fondazione Pascale

Naples, Italy

RECRUITING

Val D'Hebron

Barcelona, Spain

RECRUITING

Hospital Universitario Quirónsalud Madrid

Madrid, Spain

RECRUITING

M.D. Anderson Center Madrid

Madrid, Spain

RECRUITING

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Central Study Contacts

Ipsen Clinical Study Enquiries

CONTACT

See email; clinical.trials@ipsen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): October 3, 2028
• Study Completion (Estimated): October 3, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Locations

ES (3); IT (2); FR (3); US (5)