Not recruiting

Study of IPN01194 for Adults with Advanced Solid Tumors, Including Melanoma, Head and Neck Cancer, Pancreatic Cancer, and Colorectal Cancer

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for several types of advanced cancers, including Melanoma, Head and Neck Squamous Cell Carcinoma, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, and other Solid Tumors. The treatment being tested is a medication known by its code name, IPN01194, which is taken orally in the form of a hard capsule. The purpose of the study is to evaluate the safety and effectiveness of this medication when used alone in adult patients with these advanced cancers.

The study is divided into two phases. In the first phase, participants will receive different doses of IPN01194 to determine the safest and most effective dose. This phase will also monitor any side effects that may occur. In the second phase, the study will focus on how well the treatment works in reducing the size of the tumors. Participants will be closely monitored throughout the study to assess their response to the treatment and any changes in their condition.

Participants in the study will receive either the medication IPN01194 or a placebo. The study aims to gather information on how the body processes the medication and its impact on the tumors. This information will help researchers understand the potential benefits and risks of IPN01194 for treating these types of cancers. The study is expected to continue for several years to ensure comprehensive data collection and analysis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be informed about the trial's objectives and procedures. Consent will be obtained for the use of tumor tissue samples, either archival or fresh biopsy.
Step 2
Phase 1: initial treatment
Participants will begin treatment with the ERK1/2 inhibitor IPN01194, administered as a hard capsule taken orally.
The dosage will be determined based on the dose escalation process, which aims to find the safest and most effective dose.
The primary focus during this phase is to monitor for any dose-limiting toxicities and treatment-emergent adverse events over a 28-day cycle.
Step 3
Phase 1: monitoring and adjustments
Throughout the first phase, participants will be closely monitored for any adverse effects and the concentration of the drug in the body.
Adjustments to the dosage may be made based on the participant's response and any side effects experienced.
Step 4
Phase 2a: expanded treatment
Participants who continue to the second phase will receive the established dose of IPN01194.
The focus will be on evaluating the drug's effectiveness in reducing tumor size and progression over a period of up to 32 months.
Step 5
Ongoing assessments
Regular assessments will be conducted to measure the objective response rate, duration of response, and progression-free survival.
Participants will be monitored for any adverse events and potential dose interruptions or discontinuations.
Step 6
Completion of the study
The study is expected to conclude by March 2028, with ongoing evaluations of the treatment's safety and effectiveness throughout the trial period.

Who can join the trial?

7 criteria

Participants must be at least 18 years old.
Participants should have a confirmed diagnosis of a **metastatic solid tumor**. This means the cancer has spread from its original site to other parts of the body. The types of cancer include melanoma, colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), or head and neck squamous cell carcinoma (HNSCC). There should be no other suitable standard treatment options available for them.
Participants must have tumors with specific types of **genetic mutations** known as MAPKm.
Participants must have a disease that can be measured using a specific set of guidelines called **Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1**. This is a way to measure how the tumor responds to treatment.
Participants should have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 0 or 1. This is a scale used to assess how a patient's disease is affecting their daily living abilities. A score of 0 means fully active, and 1 means restricted in physically strenuous activity but able to carry out light work.
Participants must agree to provide a sample of their tumor tissue. If a previous sample is not available, they must agree to have a new biopsy, which is a procedure to collect a small piece of the tumor for testing.
Both male and female participants are eligible. They must use contraception methods that comply with local regulations for clinical trials.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than those specified in the study.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have medical conditions that are not allowed in the study.
Patients who are unable to follow the study procedures or instructions.
Patients who have had certain treatments or medications that are not allowed in the study.
Patients who have other health issues that might interfere with the study.
Patients who are pregnant or breastfeeding, as the study might not be safe for them.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the study medication or similar drugs.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Paris
Verified
Paris, France
Centre Leon Berard
Verified
Lyon, France
Hospital Universitario Fundacion Jimenez Diaz
Verified
Madrid, Spain

Trial locations

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Investigated drugs

IPN01194 is an investigational medication being studied for its potential to treat advanced solid tumors. It works by inhibiting the ERK1/2 pathway, which is involved in the growth and survival of cancer cells. This study aims to determine the safety and tolerability of IPN01194, as well as its effectiveness in reducing tumor size in patients.

Ipn01194

What is already known about the treatment

IPN01194 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating various types of cancer, including melanoma, head and neck squamous cell carcinoma, solid tumors, pancreatic ductal adenocarcinoma, and colorectal cancer. It is in the early stages of research, specifically in Phase I/II trials, to assess its safety, tolerability, and effectiveness. IPN01194 works by inhibiting the ERK1/2 proteins, which are part of a signaling pathway that helps cancer cells grow and divide. It is classified as an ERK1/2 inhibitor, a type of targeted cancer therapy.

Investigated diseases

Melanoma
Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. It often appears as a new mole or a change in an existing mole and can occur anywhere on the body. Melanoma can grow quickly and has the potential to spread to other parts of the body if not detected early. It is more common in areas of the skin that have been exposed to the sun, but it can also develop in areas not typically exposed.
Head and Neck Squamous Cell Carcinoma
This is a type of cancer that arises from the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It often begins as a small, painless lump or sore that does not heal. As it progresses, it can cause symptoms like difficulty swallowing, changes in voice, or persistent sore throat. The cancer can spread to nearby tissues and lymph nodes.
Solid Tumors
Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. Solid tumors can be benign, meaning they are not cancerous, or malignant, meaning they are cancerous. The growth and spread of malignant solid tumors depend on the type and location of the tumor.
Pancreatic Ductal Adenocarcinoma
This is the most common type of pancreatic cancer, originating in the ducts of the pancreas. It often grows silently and may not cause symptoms until it is advanced. When symptoms do appear, they can include jaundice, weight loss, and abdominal pain. The cancer can invade nearby tissues and spread to other parts of the body.
Colorectal Cancer
Colorectal cancer starts in the colon or rectum, which are parts of the large intestine. It typically begins as a growth called a polyp on the inner lining of the colon or rectum, which can become cancerous over time. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The cancer can grow into the wall of the colon or rectum and spread to nearby lymph nodes and other organs.