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IPN01195

IPN01195 is a novel investigational medication currently being studied for the treatment of advanced solid tumors. This first-in-human clinical trial aims to evaluate the safety, appropriate dosing, and effectiveness of IPN01195 in adult patients whose cancer has progressed to advanced stages. The study is designed in two phases: Phase I to determine the optimal dose and Phase II to further assess the drug’s anti-tumor activity. This article provides an overview of the ongoing clinical research with IPN01195, helping patients understand what this experimental treatment involves and how the clinical trial is structured.

Table of Contents

What is IPN01195?

IPN01195 is a new investigational medication that is currently being studied for the treatment of advanced solid tumors[1]. This drug is in the early stages of clinical development, specifically in a Phase I/II clinical trial, which means it is not yet approved for general use. The trial represents the first time this medication is being tested in humans (known as a first-in-human study).

What Conditions Does IPN01195 Treat?

IPN01195 is being investigated for the treatment of advanced solid tumors[1]. These are cancers that:

  • Form in solid organs or tissues (as opposed to blood cancers)
  • Have spread from their original site to nearby tissues (locally advanced)
  • May have spread to other parts of the body (metastatic)

The current clinical trial is not limited to a specific type of solid tumor, suggesting that researchers are investigating the drug’s potential effectiveness across multiple cancer types.

Clinical Trial Design

The clinical trial for IPN01195 (identified as NCT06833008) is structured as an open-label, Phase I/II study[1]. “Open-label” means that both the participants and researchers know which treatment is being given. The study is divided into two main phases:

Phase I

This initial phase is further split into two parts:

  • Part A (Dose Escalation): This part aims to find the safe dose range that shows activity against tumors. Different dose levels will be tested to determine how much of the drug patients can tolerate[1].
  • Part B (Dose Confirmation): After finding potentially effective doses in Part A, this segment will further assess how the drug works at either a “low dose” or “high dose” level. Participants will be randomly assigned to one of these dose groups[1].

Phase II

Based on the results from Phase I, the study will continue to a Phase II extension. This phase will further evaluate the drug’s effectiveness and safety at the optimal dose determined in the earlier phase[1].

How IPN01195 is Administered

The clinical trial documents indicate that IPN01195 will be administered at assigned dose levels, though the specific route of administration (such as oral or intravenous) is not explicitly stated in the available information[1]. However, since the study includes food effect assessments (comparing the drug’s absorption when taken with or without food), it’s likely that IPN01195 is administered orally.

Safety Assessment

A primary focus of this clinical trial is to evaluate the safety of IPN01195. Several safety measurements are being tracked[1]:

  • Dose-Limiting Toxicities (DLTs): These are side effects serious enough to prevent increasing the dose further. The study measures the percentage of participants experiencing DLTs within 28 days of their first dose.
  • Treatment Emergent Adverse Events (TEAEs): These are any unfavorable medical occurrences that begin after starting the study medication, whether or not they’re believed to be related to the drug.
  • Serious Adverse Events: These are more severe side effects that may require hospitalization or are life-threatening.
  • Dose Interruptions and Treatment Discontinuations: The study tracks how often treatment needs to be paused or stopped completely due to side effects.
  • QT Interval Prolongation: The study monitors for potential effects on heart rhythm, specifically looking at the QT interval (a measurement on an electrocardiogram that indicates how long it takes for the heart to recharge between beats).

How Effectiveness is Being Measured

The study uses several standard measurements to assess how well IPN01195 works against cancer[1]:

  • Objective Response Rate (ORR): This is the percentage of participants whose tumors shrink or disappear completely. A “complete response” means all detectable cancer has disappeared, while a “partial response” means the tumor has shrunk by a defined percentage.
  • Duration of Response (DoR): For patients whose tumors do respond to treatment, this measures how long that response lasts before the cancer starts growing again.
  • Progression-Free Survival (PFS): This is the time from starting treatment until the cancer starts growing again or the patient dies.
  • PFS Rate at 4 Months: The proportion of participants who are still alive and whose cancer has not progressed 4 months after starting treatment.
  • Disease Control Rate (DCR): This includes patients whose best response is complete response, partial response, or stable disease (tumor neither growing nor shrinking significantly).

Food Effects on IPN01195

Part of the study evaluates how food affects the way the body processes IPN01195[1]. This assessment compares:

  • How quickly the drug reaches its maximum concentration in the blood (Tmax)
  • The highest concentration it reaches (Cmax)
  • The total exposure to the drug over time (AUC – Area Under the Curve)

These measurements are compared when the drug is taken in a fasted state (without food) versus a fed state (with food). This information helps determine whether future patients should take the medication with or without food for optimal effectiveness.

What to Expect as a Trial Participant

Participants in the IPN01195 clinical trial can expect[1]:

  • Screening Period: Initial assessments to determine eligibility for the study.
  • Treatment Period: At least two visits during the first month, followed by monthly visits.
  • Tumor Assessments: Every 6 weeks up to Week 24, then every 12 weeks afterward to measure how the tumor is responding to treatment.
  • End of Treatment Visit: Occurring 30 days after the last dose of the study drug.
  • Monitoring Procedures: Regular blood samples, urine collections, physical examinations, and clinical evaluations throughout the study.

The total duration of the study may be up to approximately 3 years, depending on how well participants respond to the treatment.

Study Aspect Details
Drug Name IPN01195
Study Type Phase I/II, First-in-human, Open-label
Target Condition Advanced solid tumors
Study Structure Phase I (Parts A and B) followed by Phase II
Primary Objectives Determine safety, tolerability, appropriate dosage, and anti-tumor activity
Key Measurements Safety profile, tumor response rates, progression-free survival, duration of response
Assessment Schedule Tumor evaluations every 6 weeks (first 24 weeks), then every 12 weeks
Treatment Duration Up to approximately 3 years, depending on response and tolerability
Follow-up Evaluation 30 days after the last dose of study medication

FAQ

  • What is IPN01195? IPN01195 is an investigational medicine (not yet approved for general use) being studied for the treatment of advanced solid tumors. It's currently in early-stage clinical trials to determine its safety, how the body processes it, and whether it can effectively treat cancer by preventing, slowing down, or stopping tumor growth.
  • What types of cancer might IPN01195 treat? IPN01195 is being studied for 'advanced solid tumors,' which refers to cancers that form in organs or tissues and have spread to nearby tissues or other parts of the body. This can include various types of cancer that have advanced beyond early stages.
  • How is the IPN01195 clinical trial structured? The trial has two main phases. Phase I is divided into Part A (dose escalation) where different doses are tested to find a tolerable range, and Part B (dose confirmation) where selected doses are further evaluated. Based on Phase I results, the trial will move to Phase II to further study the drug's effectiveness. Throughout the trial, participants undergo regular evaluations including blood tests, physical examinations, and tumor assessments.
  • What is being measured in the IPN01195 trial? The trial measures several outcomes. For safety, researchers track side effects, adverse events, and how well patients tolerate the medication. For effectiveness, they measure response rates (whether tumors shrink), duration of response (how long tumors remain smaller), progression-free survival (time before cancer worsens), and disease control rate (percentage of patients whose cancer shrinks or remains stable).
  • How often do participants need to visit the clinic during the trial? During the first month of treatment, participants will need at least two clinic visits, followed by monthly visits thereafter. Additionally, tumor assessments occur every 6 weeks up to Week 24, then every 12 weeks afterward. A final visit occurs 30 days after the last dose of the study drug. The entire study may last up to approximately 3 years.

Ongoing Clinical Trials on IPN01195

  • Study on the Safety and Effects of IPN01195 in Adults with Advanced Solid Tumors

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

Glossary

  • Advanced Solid Tumor: Cancers that form in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.
  • Dose Escalation: A process in clinical trials where the dose of a drug is gradually increased to find the optimal balance between effectiveness and side effects.
  • Dose Limiting Toxicity (DLT): Side effects that are severe enough to prevent further increase in the dosage of a drug during clinical trials.
  • Pharmacokinetic: The study of how drugs move through the body, including how they are absorbed, distributed, metabolized, and eliminated.
  • Pharmacodynamic: The study of how drugs affect the body and how the body responds to them.
  • Adverse Event (AE): Any undesirable medical occurrence in a patient during a clinical trial, whether or not it's considered related to the treatment being studied.
  • Treatment Emergent Adverse Events (TEAEs): Adverse events that occur after the study treatment begins, which weren't present before treatment started.
  • RECIST: Response Evaluation Criteria In Solid Tumors – a standard way to measure how well a cancer patient responds to treatment based on whether tumors shrink, stay the same, or grow.
  • Objective Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Complete Response (CR): The disappearance of all signs of cancer in response to treatment.
  • Partial Response (PR): A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.
  • Stable Disease (SD): Cancer that is neither growing nor shrinking in response to treatment.
  • Disease Control Rate (DCR): The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, or stable disease.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Duration of Response (DoR): The period from when a tumor begins to shrink until it starts to grow again.
  • QT Interval: A measurement on an electrocardiogram that represents the time it takes for the heart's electrical system to fire an impulse and then recharge. Some medications can affect this interval.
  • Fasted State: When a person has not eaten for a certain period of time (usually overnight or for several hours).
  • Fed State: When a person has recently eaten a meal.
  • Cmax: The maximum concentration of a drug in the blood after it has been administered.
  • AUC (Area Under the Curve): A measurement of the total amount of drug in the bloodstream over time.

References