NCT06833008 A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours
| NCT ID | NCT06833008 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ipsen |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2025-03-14 |
| Primary Completion | 2028-10-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 85 participants in total. It began in 2025-03-14 with a primary completion date of 2028-10-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Ipsen Medical Director
STUDY DIRECTOR
Ipsen
Frequently Asked Questions
Who can join the NCT06833008 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06833008 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06833008 currently recruiting?
Yes, NCT06833008 is actively recruiting participants. Contact the research team at clinical.trials@ipsen.com for enrollment information.
Where is the NCT06833008 trial being conducted?
This trial is being conducted at Grand Rapids, United States, Nashville, United States, Dallas, United States, West Valley City, United States and 9 additional locations.
Who is sponsoring the NCT06833008 clinical trial?
NCT06833008 is sponsored by Ipsen. The principal investigator is Ipsen Medical Director at Ipsen. The trial plans to enroll 85 participants.