RecruitingPhase 1 / Phase 2

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

A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors, Including Checkpoint Inhibitor Naïve Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests EIK1005 alone and with pembrolizumab in adults with advanced solid tumors, including tumors with certain DNA repair problems. It aims to find the most effective dose that can be taken safely and learn how well people tolerate treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old when you sign the consent form.
  • You are expected to live at least 3 months.
  • Tests show you have a solid tumor that cannot be removed by surgery or has spread.
  • For Parts 1B and 2, your tumor must have DNA repair problems called MSI-H or dMMR. A saved tumor sample no more than 3 years old is required. This type of sample is recommended for Part 1A.
  • For Part 1A, your advanced cancer grew after at least one standard treatment, or you could not tolerate that treatment. Your study doctor must judge that no other treatment options are available.
  • Your cancer can be measured using the study's rules.
  • You can do all usual activities, or only have limits on hard physical activity.
  • Your organs and bone marrow, which makes blood cells, work well enough.

Who can't join

  • Side effects from past cancer treatment have not returned to mild levels or your usual health level, or you have already taken a Werner (WRN) inhibitor.
  • You have a history of drug sensitivity or allergies, including allergies to the study drug or its ingredients.
  • For Parts 1B and 2 Rescue, you have a weakened immune system, take long-term steroids above 10 mg of prednisone or an equal dose daily, or used other immune-suppressing drugs within 7 days before treatment.
  • You have another cancer that is growing or needed treatment in the past 3 years.
  • You have active cancer spread to the brain or spinal cord, or their lining. Treated brain tumors may be allowed if scans show no growth for at least 4 weeks, your condition is stable, and you have not needed steroids for at least 14 days before treatment.
  • Heart tests show an average QTcF above 470 milliseconds, a sign of delayed recovery between heartbeats.
  • You have a disease in which the immune system attacks the body that needed whole-body treatment in the past 2 years. Exceptions include type 1 diabetes, low thyroid treated with hormones, and certain skin conditions not needing whole-body treatment.
  • You have current lung inflammation or lung tissue disease, or a past case that needed steroids; active tuberculosis; or another active infection needing whole-body treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: 1. is ≥ 18 years of age at the time of signing the informed consent. 2. has a life expectancy of at least 3 months. 3. 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 has locally confirmed Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) tumor. Participant must have archival tumor tissue (not more than 3 years old) for retrospective confirmation of MSI-H or dMMR tumor by a central laboratory. 4. 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 judgement. Preference should be given to: (1) participants with MSI-H or dMMR cancers that have progressed after checkpoint inhibitor (CPI) therapy and (2) participants with microsatellite stable cells (MSS) cancers that have progressed following at least one regimen of platinum, alkylating or topoisomerase containing chemotherapy. 5. has measurable disease at baseline according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the PI. 6. has an Eastern Cooperative Oncology Group (ECOG) score of 0 to 1. 7. has an adequate organ and marrow function. Key Exclusion Criteria: 1. has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy-induced adverse events (AEs). 2. has received prior treatment with Werner (WRN) inhibitor. 3. 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 hospitalization, or any other allergic reaction in general. 4. 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 within 7 days prior to the first dose of study intervention. 5. has known additional malignancy that is progressing or has required active treatment within the past 3 years. 6. 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 evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study treatment. 7. has mean resting QTcF \> 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs). 8. 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 conditions: Type 1 diabetes, hypothyroidism requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia not requiring systemic treatment). 9. has history of (non-infectious) pneumonitis/pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease. 10. has active tuberculosis. 11. has any active infections requiring systemic therapy.

Study sites (10)

CA

FL

NJ

NY

TX