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Study of IPN01195 for Advanced Solid Tumors

This study is testing a new medicine called IPN01195 for adults with advanced solid tumors. Advanced solid tumors are cancers that have spread from their original site. The main goals are to find the right dose of IPN01195, understand its safety, and see how well it works. You might be able to join if you are at least 18 years old and have an advanced solid tumor for which other standard treatments are not suitable. The study will look at side effects and how the tumor responds to IPN01195. The current status of the study is unclear, and it plans to enroll 85 participants.

Study design
This is an interventional study with two phases (Phase I and Phase II). Phase I has two parts (A and B) to find the best dose and assess its effects. The study plans to enroll 85 participants.
What's involved
You would have at least two visits in the first month, then one visit every month. There will also be a visit 30 days after your last dose, and tumor assessments every 6-12 weeks.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects and dose interruptions from the first dose until 30 days after the last dose. Tumor assessments will continue every 6 weeks up to Week 24 and every 12 weeks thereafter.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06833008

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Ipsen
~85 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:IPN01195

At a glance

Recruiting sites
12 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Percentage of participants with dose limiting toxicity (DLT)
Measured over Part A: within 28 days of first dose.
+3 more outcomes measured

Conditions

Advanced Solid Tumor

Explore related trials

Solid NeoplasmALK Pathway

Where it's being run

13 sites across 8 states
France3
Spain3
Italy2
Michigan1
Tennessee1
Texas1
Utah1
Virginia1

Study leadership

  • Ipsen Medical Director · STUDY_DIRECTOR · Ipsen

Who to contact

Ipsen Clinical Study Enquiries
[email protected]
See email
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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).From the first IPN01195 administration to 30 days after last dose.

    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.

  • Part A and B: Percentage of participants with dose interruptions and permanent treatment discontinuationsFrom the first study drug administration to 30 days after last dose.
  • Part B: Objective response rate (ORR)Part B: At end of study (up to approximately 3 years)

    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.