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

Launched by IPSEN · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called IPN01195 to find out the right dosage, safety, and effectiveness for adults with advanced solid tumors. These are types of cancers that have spread from their original location to other parts of the body. The study is open to adults aged 18 and older who have a specific kind of metastatic solid tumor for which there are no other effective treatment options available. Participants will need to provide a sample of their tumor tissue for testing to confirm their eligibility.

If you decide to participate, you will receive the study drug and be closely monitored for any side effects and how well the treatment works. It's important to note that there are certain health conditions and treatments that may exclude you from joining the trial, such as having severe infections, certain heart or digestive issues, or being on other cancer therapies. The trial is currently recruiting participants, so if you or a loved one is interested, you can reach out to learn more about the process and how to get involved.

Gender

ALL

Eligibility criteria

• 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.