Study on a New Medicine IPN01195 for Adults with Advanced Solid Tumors

Sponsor: Ipsen

Sponsor score: 0

ClinicalTrials ID:NCT06833008

Provider View

This clinical trial is testing a new medicine called IPN01195 to find the right dose and check its safety and effectiveness in adults with advanced solid tumors, which are cancers that have spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to determine the best dose, safety, and effectiveness of a new drug, IPN01195, in adults with advanced solid tumors. These tumors are cancers that have spread from their original site to other parts of the body. The study will help understand how well the drug works and how the body handles it.

Description

The study has two phases: Phase I and Phase II.

In Phase I, there are two parts:

  • Part A: This part will test different doses of IPN01195 to find the dose that works on the tumor and is safe for patients.
  • Part B: This part will check how well the drug can stop or slow down tumor growth and how the body processes the drug at different doses.

Participants will go through:

  • A screening period to check if they qualify for the study.
  • A treatment period with at least two visits in the first month, then one visit each month. There will also be a visit 30 days after the last dose of the drug.
  • Regular assessments every 6 weeks up to Week 24, then every 12 weeks, to see how the tumor is changing.

Phase II will continue to evaluate the drug based on Phase I results.

Throughout the study, participants will have blood and urine tests, physical exams, and other evaluations. They may continue some medications, but these need to be recorded.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic solid tumor with no other suitable treatment options.
  • Tumors must have specific genetic changes in the MAPK pathway.
  • Must agree to provide a tumor sample for testing.
  • Must have measurable disease according to specific criteria.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must agree to use contraception if applicable.
  • Must be able to give informed consent and follow study requirements.

Exclusion Criteria

  • Have digestive issues that affect drug absorption.
  • Have severe infections or inflammatory conditions.
  • Have poor heart function.
  • Have mental health or substance abuse issues that affect study participation.
  • Have other medical conditions that could interfere with the study.
  • Have another cancer that is progressing or needs treatment within the last 2 years.
  • Have active brain cancer or related conditions.
  • Have participated in another clinical study within the last 28 days.
  • Have received a live vaccine within 28 days before the study.
  • Are receiving other cancer treatments.
  • Have not had a sufficient break from previous cancer treatments.
  • Need high doses of steroids or other immune-suppressing drugs.
  • Have poor bone marrow, kidney, or liver function.
  • Have HIV or uncontrolled hepatitis infections.
  • Are allergic to IPN01195 or its components.

Locations

FACILITYZIPCITYSTATE
START Mountan Region84119West Valley CityUtah

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.