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New treatment option for Advanced Solid Tumors
Official title EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors
ClinicalTrials.gov ID: NCT07262619
What this study is testing
What is EIK1005?
EIK1005 is an investigational medicine, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in treating patients with advanced cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- is ≥ 18 years of age at the time of signing the informed consent.
- has a life expectancy of at least 3 months.
- has histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor. Part 1A: recommend that participants have...
- In Part 1A, has received and then progressed after or is intolerant to at least 1 standard treatment regimen in the advanced setting. The participant...
- has measurable disease at baseline according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the PI.
You likely can't join if
- has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy-induced adverse events (AEs).
- has received prior treatment with Werner (WRN) inhibitor.
- has a history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation...
- In Parts 1B and Part 2 Rescue: diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of...
- has known additional malignancy that is progressing or has required active treatment within the past 3 years.
- has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may...
See the full eligibility criteria
- is ≥ 18 years of age at the time of signing the informed consent.
- has a life expectancy of at least 3 months.
- has histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor. Part 1A: recommend that participants have archival tissue not more than 3 years old. Part 1B and Part 2: participant...
- In Part 1A, has received and then progressed after or is intolerant to at least 1 standard treatment regimen in the advanced setting. The participant does not have alternative therapeutic options per PI's medical...
- has measurable disease at baseline according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the PI.
- has an Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
- has an adequate organ and marrow function. Key
- has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy-induced adverse events (AEs).
- has received prior treatment with Werner (WRN) inhibitor.
- has a history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients, history of serious allergic reactions leading to...
- In Parts 1B and Part 2 Rescue: diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy...
- has known additional malignancy that is progressing or has required active treatment within the past 3 years.
- has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without...
- has mean resting QTcF \> 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs).
- has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Participants may enroll with the following...
- has history of (non-infectious) pneumonitis/pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
- has active tuberculosis.
- has any active infections requiring systemic therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Morristown, New Jersey, United States
- New York, New York, United States
- Houston, Texas, United States
- Saint Leonards, New South Wales, Australia
- Waratah, New South Wales, Australia
- Ballarat, Victoria, Australia
- Camperdown, Victoria, Australia
- Frankston, Victoria, Australia
- Wellington, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Morristown, New Jersey, United States; New York, New York, United States; Houston, Texas, United States; Saint Leonards, New South Wales, Australia; Waratah, New South Wales, Australia; Ballarat, Victoria, Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.