RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-label, Phase I/II First-in-human, Dose Escalation and Confirmation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Anti-tumour Activity of IPN01195 as Single Agent in Adult Participants With Advanced Solid Tumours

Quick Facts

Study Start:2025-02-11

Study Completion:2028-10-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06833008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Ipsen Clinical Study Enquiries

CONTACT

See email

clinical.trials@ipsen.com

Principal Investigator

Ipsen Medical Director

STUDY_DIRECTOR

Ipsen

Study Locations (Sites)

START Mountan Region

West Valley City, Utah, 84119

United States

Collaborators and Investigators

Sponsor: Ipsen

Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-11

Study Completion Date2028-10-03

Study Record Updates

Study Start Date2025-02-11

Study Completion Date2028-10-03

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor