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Peposertib

Peposertib, also known as M3814, is an investigational anti-cancer drug being studied in various clinical trials. This article summarizes key information about ongoing research on peposertib for treating different types of cancer, including its potential benefits, side effects, and how it is being combined with other therapies. The trials aim to determine the safety, optimal dosing, and effectiveness of peposertib in patients with advanced solid tumors and other cancers.

Table of Contents

What is Peposertib?

Peposertib is a new anti-cancer drug that is currently being studied in clinical trials for various types of cancer. It is also known by several other names, including M3814, MSC2490484A, and Nedisertib.[1] Peposertib belongs to a class of drugs called DNA-PK inhibitors, which work by blocking certain enzymes that cancer cells need to grow and survive.[2]

How Does Peposertib Work?

Peposertib works by inhibiting an enzyme called DNA-dependent protein kinase (DNA-PK). This enzyme plays a crucial role in repairing DNA damage in cells. By blocking DNA-PK, Peposertib may prevent cancer cells from repairing their damaged DNA, ultimately leading to their death.[3] Additionally, Peposertib may enhance the effects of chemotherapy and radiation therapy by making cancer cells more vulnerable to these treatments.[4]

What Types of Cancer is Peposertib Being Studied For?

Peposertib is being investigated for various types of cancer, including:

  • Rectal cancer: Studies are looking at combining Peposertib with radiation therapy and chemotherapy for locally advanced rectal cancer.[2]
  • Glioblastoma: This is an aggressive type of brain cancer where Peposertib is being tested in combination with radiation therapy and chemotherapy.[5]
  • Advanced solid tumors: Various studies are exploring Peposertib’s effectiveness in treating different types of advanced cancers that have spread or cannot be surgically removed.[6]
  • Head and neck cancer: Peposertib is being studied in combination with radiation therapy for advanced head and neck cancers.[7]
  • Pancreatic cancer: Research is ongoing to evaluate Peposertib with radiation therapy for locally advanced pancreatic cancer.[8]
  • Ovarian cancer: Studies are investigating Peposertib in combination with chemotherapy for recurrent ovarian cancer.[9]
  • Sarcomas: Peposertib is being tested in combination with low-dose chemotherapy for advanced soft tissue sarcomas.[10]

How is Peposertib Given?

Peposertib is typically given as an oral medication, meaning patients can take it by mouth in the form of tablets or capsules. The dosing schedule may vary depending on the specific clinical trial and the type of cancer being treated. In most studies, Peposertib is taken once or twice daily, often in combination with other treatments such as radiation therapy or chemotherapy.[1][2]

Potential Side Effects

As Peposertib is still in clinical trials, the full range of potential side effects is not yet known. Researchers are closely monitoring patients for any adverse reactions. Common side effects observed in cancer treatments may include fatigue, nausea, and changes in blood cell counts. The clinical trials are designed to determine the safety profile of Peposertib and identify any specific side effects associated with its use.[1][2]

Ongoing Research

Peposertib is currently being studied in various phase I and II clinical trials. These studies aim to:

  • Determine the safe and effective dose of Peposertib when used alone or in combination with other treatments[1]
  • Evaluate how well Peposertib works in treating different types of cancer[2]
  • Assess the side effects and safety profile of Peposertib[3]
  • Study how Peposertib interacts with other cancer treatments like radiation therapy and chemotherapy[4]
  • Investigate biomarkers that may help predict which patients are most likely to benefit from Peposertib treatment[5]

It’s important to note that as Peposertib is still in the research phase, it is not yet approved for general use outside of clinical trials. Patients interested in treatments involving Peposertib should discuss potential clinical trial opportunities with their healthcare providers.

Trial ID Cancer Type Combination Therapy Phase Key Objectives
NCT04702698 Healthy volunteers None (pharmacokinetic study) I Evaluate effect of food on peposertib pharmacokinetics
NCT03770689 Rectal cancer Capecitabine and radiotherapy I/II Determine MTD, RP2D, safety, and efficacy
NCT04068194 Advanced solid tumors and hepatobiliary cancers Avelumab and radiotherapy I/II Determine safety, RP2D, and efficacy
NCT05687136 Advanced solid tumors Tuvusertib (ATR inhibitor) I Determine safety, MTD, RP2D, and pharmacokinetics
NCT04750954 Neuroendocrine tumors Lutetium Lu 177 dotatate I Determine RP2D, safety, and efficacy
NCT04092270 Ovarian cancer Pegylated liposomal doxorubicin I/II Determine safety, RP2D, and efficacy
NCT04533750 Head and neck cancer Radiation therapy I Determine RP2D, safety, and efficacy
NCT05711615 Advanced sarcoma Low-dose liposomal doxorubicin I Determine safety, MTD, RP2D, and efficacy

FAQ

  • What is peposertib and how does it work? Peposertib (also called M3814) is an investigational anti-cancer drug that works by blocking enzymes needed for cancer cell growth. It may stop tumor growth by interfering with DNA repair in cancer cells. Peposertib is being studied to see if it can enhance the effects of chemotherapy and radiation therapy in treating various types of cancer.
  • What types of cancer is peposertib being studied for? Clinical trials are investigating peposertib for several cancer types, including advanced solid tumors, ovarian cancer, head and neck cancer, pancreatic neuroendocrine tumors, sarcomas, and glioblastoma. It is being studied both alone and in combination with other cancer treatments.
  • How is peposertib given to patients in clinical trials? In most trials, peposertib is given as an oral medication (taken by mouth) either once or twice daily. The dosing schedule varies between trials, with some giving it continuously and others using intermittent dosing. The optimal dose and schedule is still being determined through these studies.
  • What are some of the potential side effects of peposertib? As peposertib is still being studied, all of its side effects are not yet known. Clinical trials are monitoring patients closely for adverse events. Some trials have reported side effects like nausea, fatigue, and changes in blood cell counts. The studies aim to determine the safety profile and identify any dose-limiting toxicities.
  • How can I find out if I'm eligible to participate in a peposertib clinical trial? Eligibility for peposertib clinical trials depends on factors like cancer type, stage, prior treatments, and overall health. Each trial has specific inclusion and exclusion criteria. If you're interested in participating, talk to your oncologist about whether any peposertib trials may be appropriate for you. You can also search for trials on clinicaltrials.gov using the term 'peposertib' or 'M3814'.

Ongoing Clinical Trials on Peposertib

  • Study on Everolimus and Drug Combination for Children with Relapsed or Refractory Pediatric Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy The Netherlands Spain

Glossary

  • Peposertib: An investigational anti-cancer drug that works by blocking enzymes needed for cancer cell growth, particularly those involved in DNA repair. Also known as M3814 or MSC2490484A.
  • DNA-PK inhibitor: A type of drug that blocks DNA-dependent protein kinase, an enzyme involved in repairing DNA damage in cells. Peposertib is a DNA-PK inhibitor.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent increasing the dose or require a dose reduction. DLTs help determine the maximum tolerated dose in clinical trials.
  • Maximum tolerated dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects. The MTD is determined in phase I clinical trials.
  • Recommended phase 2 dose (RP2D): The dose of a drug selected for further testing in phase II clinical trials, based on safety and efficacy data from phase I trials.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body. PK studies help determine optimal dosing.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment based on changes in tumor size.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.

References

  1. https://clinicaltrials.gov/study/NCT04702698
  2. https://clinicaltrials.gov/study/NCT03770689
  3. https://clinicaltrials.gov/study/NCT04068194
  4. https://clinicaltrials.gov/study/NCT04750954
  5. https://clinicaltrials.gov/study/NCT04555577
  6. https://clinicaltrials.gov/study/NCT05687136
  7. https://clinicaltrials.gov/study/NCT04533750
  8. https://clinicaltrials.gov/study/NCT04172532
  9. https://clinicaltrials.gov/study/NCT04092270
  10. https://clinicaltrials.gov/study/NCT05711615