Assessing a new medicine called IPN01195 for advanced solid tumors
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
This study is testing a new medicine called IPN01195 to see if it can safely help adults with advanced solid tumors by slowing or stopping their growth.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ipsen Industry-sponsored |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 13 sites (Grand Rapids, Michigan and 12 other locations) |
| Trial ID | NCT06833008 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety, dosage, and effectiveness of a new drug, IPN01195, in adults with advanced solid tumors. It consists of two phases: Phase I, which includes dose escalation and confirmation to determine the optimal dosage and assess the drug's ability to slow or stop tumor growth, and Phase II, which will further evaluate the drug based on Phase I results. Participants will undergo various assessments, including blood tests, physical exams, and tumor evaluations throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic solid tumors and specific genetic alterations in the MAPK pathway.
Not a fit: Patients without advanced solid tumors or those who have suitable alternative standard therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.
How similar studies have performed: Other studies have shown promise with similar approaches targeting the MAPK pathway, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Grand Rapids, Michigan and 12 other locations
- START Mid-West — Grand Rapids, Michigan, United States (Recruiting)
- Sarah Cannon Research Institute (SCRI) - Nashville — Nashville, Tennessee, United States (Recruiting)
- Mary Crowley Cancer Research Centers - Medical City Hospital - Dallas — Dallas, Texas, United States (Recruiting)
- START Mountan Region — West Valley City, Utah, United States (Recruiting)
- Virginia Cancer Specialist- Fairfax — Fairfax, Virginia, 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 contacts
- Study coordinator: Ipsen Clinical Study Enquiries
- Email: clinical.trials@ipsen.com
- Phone: See email
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.