A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
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
2 other identifiers
interventional
220
3 countries
12
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2024
Longer than P75 for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedStudy Start
First participant enrolled
April 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 20, 2028
April 30, 2026
April 1, 2026
4 years
February 27, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Phase 1: Percentage of participants with dose limiting toxicity (DLT)
Within 28 days of first dose
Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs)
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
At 30 days following the last administration of study intervention
Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations
At 30 days following the last administration of study intervention
Phase 2a: Objective response rate (ORR)
Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator.
At end of treatment (up to approximately 32 months)
Secondary Outcomes (14)
Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194
At Day 1 and Day 15.
Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194
At Day 1 and Day 15.
Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194
At Day 1 and Day 15.
Phase 1: Geometric mean ratio of Cmax of IPN01194 administered in fed state relative to fasted state
Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state
Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
- +9 more secondary outcomes
Study Arms (2)
Phase I (Dose Escalation with Backfilling)
EXPERIMENTALNine dose levels are planned to be tested.
Phase IIa (Cohort Expansion)
EXPERIMENTALStudy intervention will be administered at one of two doses of interest determined at the end of Phase I.
Interventions
IPN01194 will be taken orally over a period of 28 days (a "Cycle") at the assigned dose level. The dose limiting toxicity (DLT) observation period consists of the first 28 days of treatment with IPN01194 (Cycle 1). Participants will receive IPN01194 treatment beyond Cycle 1 until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (12)
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
Centre Léon Bérard - Lyon
Lyon, France
Paris Saint-Louis
Paris, France
Institut de Cancerologie de l'Ouest (St-Herblain)
Saint-Herblain, France
IGR-Villejuif
Villejuif, France
Barcelona - Val D'Hebron
Barcelona, Spain
Fundacion Jimenez Diaz - Madrid
Madrid, Spain
M.D. Anderson Cancer Center Madrid
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2024
First Posted
March 12, 2024
Study Start
April 3, 2024
Primary Completion (Estimated)
March 20, 2028
Study Completion (Estimated)
March 20, 2028
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
- Access Criteria
- Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.