In short
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.
At a glance
- 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
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. 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.
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. 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.
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)
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:
- 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).
- Part 2 (Dose Optimization): This phase further evaluates different dose levels of EIK1003 to find the optimal dose for future studies.
- 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).
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
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.
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)
Patients considering participation in an EIK1003 trial should discuss potential risks and benefits thoroughly with their healthcare provider.