Study on IPN01194 for Adults with Advanced Solid Tumors

Sponsor: Ipsen

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06305247

Provider View

This clinical trial is testing a new oral medication, IPN01194, to find the right dose and evaluate its safety and effectiveness in adults with advanced solid tumors, which are cancers that have spread from their original site.

Patient Parameters

Program Overview

The study aims to determine the best dosage, safety, and effectiveness of the drug IPN01194 in adults with advanced solid tumors. These tumors are cancers that have spread from their original location to other parts of the body. All participants will take the study drug orally.

Description

The study is divided into two parts: Phase I and Phase IIa.

In Phase I, researchers will test different doses of IPN01194 to find the highest dose that is safe and shows activity against the tumor. This phase will also look at how the body processes the drug with and without food.

In Phase IIa, participants with a specific type of tumor will be invited to join. Two doses identified from Phase I will be tested, and participants will be randomly assigned to one of these doses.

Each phase includes three periods:

  1. Screening Period: Up to 28 days to check if participants are eligible.
  2. Treatment Period: At least 28 days with at least two visits in the first month, then monthly visits. A final visit will occur at least 30 days after the last dose.
  3. Follow-up Period (Phase IIa only): Every 3 months, participants will be contacted by phone until the study ends or the participant passes away.

Participants will have blood and urine tests, physical exams, and clinical evaluations. They may continue some medications, but these must be recorded.

If a participant is benefiting from the treatment after the study ends, they may continue receiving the drug until the cancer progresses, side effects become unacceptable, or other criteria for stopping are met.

Eligibility Criteria

Inclusion Criteria :

  • Participants must be ≥18 years of age
  • Participants with histologically confirmed metastatic solid tumour (melanoma, metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head and neck squamous cell carcinoma (HNSCC)) for whom no suitable alternative standard therapy exists.
  • Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm).
  • 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.
  • Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening
  • Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.

Exclusion Criteria

  • Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications.
  • Any evidence of severe active infection or inflammatory condition.
  • Non-adequate cardiac function
  • Have one or more of study defined ophthalmological findings/conditions
  • 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 within the last 2 years prior to first dose of study intervention..
  • Major surgery within 28 days prior to first dose of study intervention.
  • Ongoing AEs caused by any prior anti-cancer therapy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0).
  • Active brain metastases or leptomeningeal metastases
  • Current enrolment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days.
  • Live vaccine(s) within 28 days prior to first dose of study intervention
  • Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
  • Treatment with medications that prolong the QT/QTc interval.
  • Treatment with strong and moderate CYP3A4 inducers
  • Treatment with strong or moderate inhibitors of CYP3A4
  • Only for Phase I participants assigned to dose escalation and low-dose backfill participants: treatment with proton pump inhibitors within 14 days prior to first dose of study intervention.
  • Non-adequate bone marrow function
  • Non-adequate renal function
  • Non-adequate hepatic function
  • Non adequate coagulation function.
  • Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C
  • Sensitivity to IPN01194 or any of its components.

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