RECRUITING

A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 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. In this study, all participants will receive the study drug, which will be taken by mouth (orally).

Official Title

An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours

Quick Facts

Study Start:2024-04-03
Study Completion:2028-03-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06305247

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ipsen Clinical Study Enquiries
CONTACT
See e mail
clinical.trials@ipsen.com

Principal Investigator

Ipsen Medical Director
STUDY_DIRECTOR
Ipsen

Study Locations (Sites)

The Angeles Clinic and Research Institute - California
Los Angeles, California, 90025
United States
UC San Diego Health System - La Jolla
San Diego, California, 92037
United States
Yale Cancer Center - New Heaven
New Haven, Connecticut, 06510
United States
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee, 37203
United States
Virginia Cancer Specialist
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Ipsen

  • Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-03
Study Completion Date2028-03-20

Study Record Updates

Study Start Date2024-04-03
Study Completion Date2028-03-20

Terms related to this study

Additional Relevant MeSH Terms

  • Melanoma
  • Head and Neck Squamous Cell Carcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Colorectal Cancer
  • Solid Tumor