EIK1005 + Pembrolizumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer treatment, EIK1005 (an experimental treatment), both alone and with pembrolizumab (an immunotherapy drug), to determine the safest and most effective dose for patients with advanced cancer. Researchers aim to assess patient tolerance, especially in those with tumors that have genetic markers called MSI-H or dMMR. Individuals with advanced cancer who have not responded to other treatments might be suitable candidates, particularly if their tumors possess these specific markers. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop taking my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic systemic steroid therapy or immunosuppressive therapy, you may need to stop these at least 7 days before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier research has shown EIK1005's potential as a treatment for certain types of cancer. It is noncytotoxic, meaning it doesn't kill cells directly, which can be a positive sign for safety. However, researchers are still collecting more detailed safety information about EIK1005 alone.
For the combination treatment, pembrolizumab (also known as Keytruda) has been used in other cancer treatments and has a well-known safety record. Most people tolerate it well, though some may experience side effects like tiredness, skin rash, or diarrhea. Serious side effects are less common but can occur.
The trial's main goal is to find the best dose of EIK1005 that people can take safely, both alone and with pembrolizumab. For those considering participation, studies indicate that researchers are carefully monitoring the treatments for safety.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for certain advanced solid tumors, which typically involve chemotherapy or radiation, EIK1005 presents a fresh approach by potentially targeting tumor cells with a novel mechanism. Researchers are excited about EIK1005 because it’s being tested both as a stand-alone treatment and in combination with pembrolizumab, a well-known immunotherapy. This combination could potentially enhance the immune system's ability to recognize and destroy cancer cells more effectively, especially in tumors with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) characteristics. By exploring dose escalation and optimization, the study aims to find the most effective and safe way to deliver EIK1005, offering new hope for patients who have limited options.
What evidence suggests that this trial's treatments could be effective for advanced cancer?
Studies have shown that EIK1005 targets certain types of cancer with specific genetic features, known as MSI-H or dMMR solid tumors. This means it focuses on cancers with particular genetic markers. Early research suggests that EIK1005 could be effective because it attacks cancer cells without harming normal cells. In this trial, some participants will receive EIK1005 as monotherapy, while others will receive a combination of EIK1005 with pembrolizumab. Pembrolizumab, a well-known cancer treatment, helps the immune system fight cancer and has already proven effective in treating MSI-H or dMMR cancers in many patients. Researchers are studying this combination treatment because it could potentially enhance pembrolizumab's effectiveness by adding another way to combat the cancer.13567
Who Is on the Research Team?
Nilou Mobashery, MD
Principal Investigator
Eikon Therapeutics, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors, including specific types such as colorectal polyposis syndrome, gastric cancer, and others. Participants must have a type of tumor known to respond to immunotherapy (MSI-H) or have Lynch syndrome.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1A (Monotherapy Dose Escalation)
Participants receive EIK1005 as monotherapy to determine the dose escalation
Part 1B (Combination Dose Escalation)
Participants receive EIK1005 in combination with pembrolizumab for dose escalation
Part 2 (Dose Optimization)
Participants are randomized to receive EIK1005 monotherapy at one of the two selected doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EIK1005
- Pembrolizumab
Trial Overview
The study is testing EIK1005's highest safe dose and its effectiveness alone or combined with Pembrolizumab in treating advanced cancers. It aims to find the right balance between safety and potential benefits.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) advanced solid tumors will be randomized to receive EIK1005 monotherapy at one of the two identified doses selected from Part 1A.
EIK1005 will be given in combination with pembrolizumab to participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) solid tumors.
EIK1005 will be given as monotherapy in participants without alternative treatment options.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eikon Therapeutics
Lead Sponsor
Citations
Helicase inhib News
A phase 1 clinical trial with HRO761 is currently ongoing to assess the safety, tolerability, and preliminary anti-tumor activity in patients with MSI high ...
A Clinical Research Study Evaluating EIK1005, a Werner ...
The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely.
ANZCTR - Registration
EIK1005 is noncytotoxic and is being considered as a potential targeted therapy in patients with MSI-H or dMMR solid tumors. EIK1005 or placebo ...
Eikon Therapeutics to Present New Phase 2 Data on ...
“EIK1001 represents a unique approach to stimulating the immune system, and we are encouraged by its potential to improve outcomes for patients ...
EIK-1005 - Drug Targets, Indications, Patents
The preclinical data demonstrated the molecule's selectivity to treat MSI-H solid tumors and potential to be developed clinically as both a monotherapy agent ...
Eikon Therapeutics to Present New Phase 2 Data ...
The trial's primary objective is to evaluate the safety and tolerability of EIK1001 in the triplet combination. In addition, Eikon hopes to ...
Eikon Therapeutics to Present New Phase 2 Data on ...
Presentation highlights novel TLR7/8 co-agonist in combination with pembrolizumab and chemotherapy in late-stage NSCLC.
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