Trial Title:
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
NCT ID:
NCT06305247
Condition:
Melanoma
Head and Neck Squamous Cell Carcinoma
Pancreatic Ductal Adenocarcinoma
Colorectal Cancer
Solid Tumor
Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Phase I is a dose escalation with backfill in participants with selected MAPKm advanced
solid tumours.
Phase IIa (cohort expansion) is an open label randomised study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IPN01194
Description:
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.
Arm group label:
Phase I (Dose Escalation with Backfilling)
Intervention type:
Drug
Intervention name:
IPN01194
Description:
All participants will receive IPN01194 orally for 28-day cycles at one of the two dose
levels determined at the end of Phase I.
Participants will receive IPN01194 treatment until treatment is precluded by toxicity,
disease progression, or upon participant's request or investigator decision
Arm group label:
Phase IIa (Cohort Expansion)
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).
Detailed description:
The study consists of two parts, called Phase I and Phase IIa.
Phase I is designed to assess the safety of increasing doses of IPN01194 in participants
with specific types of advanced solid tumours.
The aim of this "dose escalation" phase is to find the dose range showing activity on the
tumor that can be tolerated by the participants, and to determine the two doses for
further testing in Phase IIa. Phase I will assess how the body processes and responds to
the study drug when administered with and without food.
In Phase IIa, participants with selected single tumour type will be invited to take part.
During this phase, the two dose levels of the study drug identified from Phase I will be
tested. Participants will take the study drug one of the two dose levels. Each
participant will be assigned to a dose level at random (by chance).
Each phase will consist of three periods:
1. A period to assess eligibility (screening period) that will take up to 28 days.
2. A treatment period of at least 28 days that will require at least two visits for the
first month followed by one visit every month. There will be also one visit, at the
end of treatment, at least 30 days after the last administration of study drug.
3. A follow-up period (Phase IIa participants only), where every 3 months, participants
will be contacted by phone, until death or the study cut-off date, whichever comes
first.
Participants will undergo blood samplings, urine collections, physical examinations, and
clinical evaluations. They may continue some other medications, but the details need to
be recorded.
If in the opinion of the investigator a participant is continuing to experience clinical
benefit after the cut-off date, the participant may remain in the study and continue to
receive the study drug until either disease progression, unacceptable toxicity or other
withdrawal criteria are met.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Angeles Clinic and Research Institute - California
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
UC San Diego Health System - La Jolla
Address:
City:
San Diego
Zip:
92037
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Yale Cancer Center - New Heaven
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Sarah Cannon Research Institute (SCRI) - Nashville
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialist
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Centre Léon Bérard - Lyon
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Paris Saint-Louis
Address:
City:
Paris
Country:
France
Status:
Recruiting
Facility:
Name:
Institut de Cancerologie de l'Ouest (St-Herblain)
Address:
City:
Saint-Herblain
Country:
France
Status:
Not yet recruiting
Facility:
Name:
IGR-Villejuif
Address:
City:
Villejuif
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Barcelona - Val D'Hebron
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Fundacion Jimenez Diaz - Madrid
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
M.D. Anderson Cancer Center Madrid
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Start date:
April 3, 2024
Completion date:
March 20, 2028
Lead sponsor:
Agency:
Ipsen
Agency class:
Industry
Source:
Ipsen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06305247
