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Eik1003

This article discusses the ongoing clinical trials of EIK1003 (also known as IMP1734), a novel PARP1 selective inhibitor being studied for the treatment of advanced solid tumors. The trials aim to evaluate the safety, tolerability, and effectiveness of EIK1003 as both a monotherapy and in combination with other anti-cancer agents. The study focuses on patients with various types of advanced cancers, including ovarian, breast, prostate, and pancreatic cancers.

Table of Contents

What is EIK1003?

EIK1003, also known as IMP1734, IMPA220119, or IPM17134, is a new drug being developed to treat various types of advanced solid tumors[1]. It is currently undergoing clinical trials to evaluate its safety and effectiveness in cancer patients. EIK1003 is taken orally in the form of tablets, available in 5mg and 20mg strengths[1].

How does EIK1003 work?

EIK1003 is a PARP1 selective inhibitor. PARP1 (Poly ADP-ribose polymerase 1) is an enzyme that plays a crucial role in DNA repair. By inhibiting PARP1, EIK1003 can potentially prevent cancer cells from repairing their DNA, leading to their death[1]. This mechanism is particularly effective against cancer cells with certain genetic mutations, such as those in the BRCA1, BRCA2, PALB2, RAD51B, RAD51C, or RAD51D genes[1].

What conditions can EIK1003 treat?

EIK1003 is being studied for the treatment of several types of advanced solid tumors, including:

  • Epithelial ovarian cancer (EOC), fallopian tube, or primary peritoneal cancer
  • Advanced, recurrent, or metastatic HER2-negative breast cancer
  • Metastatic prostate cancer, including both castration-resistant (mCRPC) and castration-sensitive (mCSPC) types
  • Advanced, recurrent, or metastatic pancreatic ductal adenocarcinoma (PDAC)[1]

These are all serious forms of cancer that have either spread to other parts of the body or have come back after initial treatment.

Current research on EIK1003

EIK1003 is currently being studied in a comprehensive clinical trial that consists of three parts:

  1. Part 1 (Dose Escalation): This phase aims to determine the safe dose of EIK1003, both when used alone and in combination with other cancer drugs. It also assesses how the body processes the drug (pharmacokinetics) and its effects on the body (pharmacodynamics)[1].
  2. Part 2 (Dose Optimization): This phase further evaluates different dose levels of EIK1003 to find the optimal dose for future studies[1].
  3. Part 3 (Dose Expansion): This phase assesses the effectiveness and safety of EIK1003 at the selected dose in larger groups of patients. It includes patients who have never received PARP inhibitor treatment before (PARPi-naïve) and those who have received one prior PARP inhibitor treatment (PARPi-treated)[1].

Who can participate in EIK1003 trials?

The eligibility criteria for EIK1003 trials are quite specific. Generally, participants must:

  • Be 18 years or older
  • Have an advanced solid tumor of the types mentioned earlier
  • Have received at least one prior chemotherapy treatment
  • Have certain genetic mutations (for some parts of the study)
  • Have adequate organ function
  • Have a life expectancy of at least 12 weeks
  • Be willing to use effective contraception during the study[1]

There are also several conditions that may exclude someone from participating, such as certain heart conditions, active infections, or recent treatment with other experimental drugs[1].

Potential side effects and safety considerations

As EIK1003 is still in clinical trials, all its potential side effects are not yet known. The study is closely monitoring for any adverse events, particularly focusing on:

  • Changes in blood tests (laboratory parameters)
  • Changes in vital signs
  • Changes in heart rhythm (ECGs)
  • Any other treatment-emergent adverse events (TEAEs)[1]

Patients considering participation in an EIK1003 trial should discuss potential risks and benefits thoroughly with their healthcare provider.

Aspect Details
Drug Name EIK1003 (IMP1734)
Drug Type PARP1 selective inhibitor
Administration Oral tablets (5mg and 20mg)
Target Conditions Advanced solid tumors (ovarian, breast, prostate, pancreatic cancers)
Trial Phase Phase 1/2
Trial Structure Part 1: Dose escalation (monotherapy and combination)
Part 2: Dose optimization
Part 3: Dose expansion
Primary Objectives Safety, tolerability, maximum tolerated dose, recommended dose for expansion, overall response rate
Secondary Objectives Pharmacokinetics, pharmacodynamics, efficacy measures (e.g., progression-free survival, overall survival)
Key Eligibility Criteria Adults with advanced solid tumors, specific prior treatments, some genetic mutation requirements

FAQ

  • What is EIK1003 and how does it work? EIK1003 (also known as IMP1734) is a PARP1 selective inhibitor. It works by targeting a specific enzyme called PARP1, which is involved in DNA repair. By inhibiting this enzyme, EIK1003 may help prevent cancer cells from repairing their DNA, potentially leading to their death.
  • What types of cancers are being studied in these trials? The trials are focusing on advanced solid tumors, including epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, HER2-negative breast cancer, metastatic prostate cancer, and pancreatic ductal adenocarcinoma.
  • How is EIK1003 being administered in the trials? EIK1003 is being administered orally in tablet form. The trials are testing different dosages and combinations with other anti-cancer agents to determine the most effective and safe treatment approach.
  • Who is eligible to participate in these trials? Eligibility varies depending on the specific part of the trial, but generally includes adults (18 years or older) with advanced solid tumors who have received prior treatments. Some parts of the trial require participants to have specific genetic mutations or treatment histories.
  • What are the main goals of these clinical trials? The main objectives of these trials are to evaluate the safety and tolerability of EIK1003, determine the appropriate dosage, assess its effectiveness in treating various types of advanced cancers, and study how the drug behaves in the body (pharmacokinetics and pharmacodynamics).

Ongoing Clinical Trials on Eik1003

  • Study of IMP1734, Paclitaxel, and Abiraterone for Patients with Advanced Solid Tumors

    Recruiting

    2 1 1 1
    Investigated drugs:
    Denmark France Spain

Glossary

  • PARP1 selective inhibitor: A type of drug that specifically targets and blocks the activity of the PARP1 enzyme, which is involved in DNA repair. This can potentially prevent cancer cells from repairing their DNA, leading to their death.
  • Advanced solid tumors: Cancers that have spread beyond their original site to other parts of the body, forming solid masses of cancerous tissue.
  • Monotherapy: Treatment using a single drug or therapeutic approach.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and therapeutic effects.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Recommended Dose for Expansion (RDE): The dose of a drug determined to be safe and potentially effective, which is then used in larger studies to further evaluate its efficacy.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standardized method for measuring tumor response to treatment in cancer clinical trials.
  • Overall Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives without their cancer getting worse.

References

  1. http://clinicaltrials.eu/trial/study-of-imp1734-paclitaxel-and-abiraterone-for-patients-with-advanced-solid-tumors/