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3-Fluoro-5-{[(2Ar,4S)-1,1,2,2,4-Pentafluoro-2A-Hydroxy-2,2A,3,4-Tetrahydro-1H-Cyclopenta[Cd]Inden-5-Yl]Oxy}Benzonitrile

This article discusses the ongoing clinical trials investigating the use of NKT2152, also known as 3-Fluoro-5-{[(2Ar,4S)-1,1,2,2,4-Pentafluoro-2A-Hydroxy-2,2A,3,4-Tetrahydro-1H-Cyclopenta[Cd]Inden-5-Yl]Oxy}Benzonitrile, in patients with advanced liver cancers. The drug is being studied as part of a larger Phase Ib/II clinical trial called MORPHEUS-Liver, which aims to evaluate the efficacy and safety of various immunotherapy-based treatment combinations. NKT2152 is a small molecule HIF2α inhibitor that is being tested in combination with other treatments to potentially improve outcomes for patients with advanced liver cancer.

Table of Contents

What is NKT2152?

NKT2152 is a new medication being studied for the treatment of advanced liver cancer. It’s also known by its scientific name, which is quite long: 3-fluoro-5-{[(2ar,4s)-1,1,2,2,4-pentafluoro-2a-hydroxy-2,2a,3,4-tetrahydro-1h-cyclopenta[cd]inden-5-yl]oxy}benzonitrile. The medication is taken orally in the form of a hard capsule.[1]

How does NKT2152 work?

NKT2152 is classified as a small molecule HIF2α inhibitor. This means it targets a specific protein in cancer cells called HIF2α. HIF2α plays a role in helping cancer cells survive and grow, especially in low-oxygen conditions. By blocking this protein, NKT2152 aims to slow down or stop the growth of liver cancer cells.[1]

Clinical Trial Information

NKT2152 is currently being studied in a clinical trial called MORPHEUS-LIVER. This is a Phase Ib/II study, which means it’s testing both the safety and effectiveness of the drug. The trial is specifically looking at NKT2152 in combination with other cancer treatments for patients with advanced liver cancer.[1]

Who can participate in the trial?

The trial is looking for patients with specific characteristics. Here are some of the main criteria:

  • Adults aged 18 or older
  • Diagnosed with advanced liver cancer (specifically hepatocellular carcinoma or HCC) that can’t be treated with surgery
  • Have not received any previous systemic treatment for their liver cancer
  • Are in relatively good health overall (able to carry out daily activities with minimal assistance)

There are also some reasons why a person might not be able to participate, such as having certain other medical conditions or having received specific treatments in the past.[1]

What to expect during the trial

If you participate in this trial, you may receive NKT2152 in combination with other cancer treatments. The study is designed to compare different treatment combinations to see which works best. You’ll be randomly assigned to one of several treatment groups.

Throughout the study, doctors will monitor your health closely. They’ll be looking at several things:

  1. How well the treatment is working to shrink or control your cancer
  2. Any side effects you might experience
  3. How long the treatment keeps working
  4. How the treatment affects your overall survival

The doctors will use various tests, including scans and blood tests, to keep track of these factors.[1]

Potential benefits of NKT2152

While it’s important to remember that NKT2152 is still being studied and its benefits are not yet proven, researchers hope it might offer several advantages:

  • A new option for patients with advanced liver cancer who haven’t had other treatments
  • Potential to slow down or stop the growth of liver cancer
  • Possibility of working well in combination with other cancer treatments
  • Convenience of being taken orally as a capsule, rather than requiring injections or infusions

However, like all medications, NKT2152 may also have side effects. The ongoing clinical trial will help researchers better understand both the benefits and risks of this new treatment.[1]

Aspect Details
Study Type Phase Ib/II, open-label, multicenter, randomized umbrella study
Target Condition Advanced liver cancers (hepatocellular carcinoma)
Main Objective Evaluate efficacy and safety of immunotherapy-based treatment combinations
Primary Endpoints Objective response rate (ORR), safety assessment
Key Eligibility Criteria Adults with advanced HCC, no prior systemic treatment, Child-Pugh class A
NKT2152 Information Small molecule HIF2α inhibitor, administered orally as hard capsules
Study Design Multiple treatment arms, flexible to add or close arms based on results

FAQ

  • What is the main purpose of the clinical trial involving NKT2152? The main purpose of the clinical trial is to evaluate the efficacy and safety of multiple immunotherapy-based treatment combinations, including NKT2152, in patients with advanced liver cancers. The study aims to assess the objective response rate (ORR) and monitor any adverse events associated with these treatments.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults (18 years or older) with locally advanced, metastatic, or unresectable hepatocellular carcinoma (HCC) that has been confirmed by diagnosis. They must have an ECOG Performance Status of 0 or 1, Child-Pugh class A liver function, and no prior systemic treatment for HCC.
  • What is NKT2152 and how is it administered? NKT2152 is a small molecule HIF2α inhibitor. It is administered orally in the form of hard capsules. The drug is being tested in combination with other treatments as part of the MORPHEUS-Liver study.
  • What are the primary endpoints of the study? The primary endpoints of the study include the objective response rate (ORR) as determined by the investigator, the incidence and severity of adverse events and laboratory abnormalities, changes in vital signs and ECG parameters, and changes in targeted clinical laboratory test results.
  • How is the study designed? The study is designed as a Phase Ib/II, open-label, multicenter, randomized umbrella study. It has multiple treatment arms, including several experimental arms testing different drug combinations. The study is flexible, allowing for the addition of new treatment arms, closure of ineffective arms, and modifications to the patient population as needed.

Ongoing Clinical Trials on 3-Fluoro-5-{[(2Ar,4S)-1,1,2,2,4-Pentafluoro-2A-Hydroxy-2,2A,3,4-Tetrahydro-1H-Cyclopenta[Cd]Inden-5-Yl]Oxy}Benzonitrile

  • Study on the Effectiveness and Safety of TPST-1120 and Drug Combination for Patients with Advanced Liver Cancer

    Recruiting

    1 1 1 1
    Investigated drugs:
    France

Glossary

  • Hepatocellular Carcinoma (HCC): The most common type of primary liver cancer that begins in the main type of liver cell (hepatocyte).
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Child-Pugh Class: A scoring system used to assess the prognosis of chronic liver disease, mainly cirrhosis. Class A indicates the best liver function among patients with cirrhosis.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • 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.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
  • HIF2α Inhibitor: A type of drug that blocks the action of Hypoxia-Inducible Factor 2-alpha, a protein involved in cancer growth and progression.
  • Immunotherapy: A type of cancer treatment that helps the immune system fight cancer.
  • Umbrella Study: A type of clinical trial that tests the impact of different drugs on different mutations in a single type of cancer.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-tpst-1120-and-drug-combination-for-patients-with-advanced-liver-cancer/