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
EIK1005: EIK1005 is a selective inhibitor of the Werner helicase.
pembrolizumab (KEYTRUDA® ): Pembrolizumab is a PD-1 inhibitor.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose-Limiting Toxicity (DLT) - Part 1 — 21 Days A DLT is a protocol-defined adverse event occurring during the DLT observation period.
Adverse Events (AEs) - Part 1 and Part 2 — From the time of first dose of study medication through 30 days following cessation of study treatment. Number of participants reporting adverse events or serious adverse events.
Trial sites (35)
Facility
City
Region
Status
California Research Institute (CRI)
Los Angeles
California
Recruiting
Omnicure Clinical Research
Doral
Florida
Recruiting
Bioresearch Partner
Hialeah
Florida
Recruiting
Florida Clinical Trials Group
Plantation
Florida
Recruiting
Florida Clinical Trials Group - Tamarac
Tamarac
Florida
Recruiting
Morristown Medical Center
Morristown
New Jersey
Recruiting
START New York-Long Island
Lake Success
New York
Recruiting
Memorial Sloan Kettering Cancer Center (MSKCC)
New York
New York
Recruiting
START Dallas Fort Worth
Fort Worth
Texas
Recruiting
University of Texas MD Anderson Cancer Center
Houston
Texas
Recruiting
GenesisCare North Shore (Oncology)
Saint Leonards
New South Wales
Not Yet Recruiting
Calvary Mater Newcastle Hospital
Waratah
New South Wales
Recruiting
Grampians Health
Ballarat
Victoria
Recruiting
Chris O'Brien Lifehouse (Sydney Cancer Centre)
Camperdown
Victoria
Recruiting
Oncology Clinics Victoria (OCV) - Cabrini Brighton Hospital
Frankston
Victoria
Recruiting
Peninsula and Southeast Oncology (PASO) Medical
Frankston
Victoria
Recruiting
Ordensklinikum Linz Elisabethinen
Linz
Austria
Recruiting
Centre Hospitalier Universitaire Brugmann - Victor Horta
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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