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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

ConditionsAdvanced Solid TumorsMSI-H or dMMR Advanced Solid TumorsMSI-H/dMMR Gastric CancerMSI-H/dMMR Colorectal CancerMSI-H/dMMR Gastroesophageal-junction CancerEndometrial CancerMismatch Repair Deficient or MSI-High Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEikon Therapeutics

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 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.

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.

Disqualifiers

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 hospitalization, or any other allergic reaction in general.

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • EIK1005

    Drug

    EIK1005 is a selective inhibitor of the Werner helicase.

  • pembrolizumab (KEYTRUDA® )

    Drug

    Pembrolizumab is a PD-1 inhibitor.

Treatment groups

160 Participants
are divided into 3 treatment groups
Group A: Part 1A (Dose escalation, Monotherapy)Experimental treatment 1 intervention
Group B: Part 1B (Dose escalation, Combination with pembrolizumab)Experimental treatment 2 interventions
Group C: Part 2 (Dose optimization, Monotherapy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity (DLT) - Part 1

A DLT is a protocol-defined adverse event occurring during the DLT observation period.

Time frame
21 Days
2

Adverse Events (AEs) - Part 1 and Part 2

Number of participants reporting adverse events or serious adverse events.

Time frame
From the time of first dose of study medication through 30 days following cessation of study treatment.

Secondary outcomes

1

Objective Response (OR) - Part 1 and Part 2

OR defined as participants who have a complete response \[CR\] or partial response \[PR\] by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1 as assessed by the Investigator.

Time frame
Through study completion, an average of 2 years.
2

Duration of Response (DOR) - Part 1 and Part 2

DOR (defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR) by RECIST 1.1 as assessed by the Investigator.

Time frame
Through study completion, an average of 2 years.
3

Disease Control (DC) - Part 1 and Part 2

DC defined as participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) by RECIST 1.1 as assessed by the Investigator.

Time frame
Through study completion, an average of 2 years.
4

Progression-free survival (PFS) - Part 2

PFS defined as the time from randomization to the first documented disease progression by RECIST 1.1 as assessed by the Investigator or death due to any cause, whichever occurs first.

Time frame
Through study completion, an average of 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eikon Therapeutics

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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