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Advanced Solid TumorsPhase 1/2NCT07262619

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 Phase 1/2 study testing EIK1005 and pembrolizumab (KEYTRUDA® ) in people with Advanced Solid Tumors and MSI-H or dMMR Advanced Solid Tumors, run by Eikon Therapeutics at 35 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EIK1005 and pembrolizumab (KEYTRUDA® )
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
35 sitesin 14 countries
Study dates
20 Jan 2026to Mar 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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.
  • 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 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.
Show all 11Show fewer
  • 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 conditions: Type 1 diabetes, hypothyroidism requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia not requiring systemic treatment).
  • 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.

Trial locations and contacts

35 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Ana C Mamede, PharmD contact

347-806-4584

mamedea@eikontx.com

Krishna Kaza contact

kazak@eikontx.com

35 sites in 14 countries

United States10 sites, 10 recruiting

  • Omnicure Clinical Research

    Doral, Florida, 33172

    Recruiting

  • START Dallas Fort Worth

    Fort Worth, Texas, 76104

    Recruiting

  • Bioresearch Partner

    Hialeah, Florida, 33013

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • START New York-Long Island

    Lake Success, New York, 11042

    Recruiting

  • California Research Institute (CRI)

    Los Angeles, California, 90027

    Recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07960

    Recruiting

  • Memorial Sloan Kettering Cancer Center (MSKCC)

    New York, New York, 10022

    Recruiting

  • Florida Clinical Trials Group

    Plantation, Florida, 33322

    Recruiting

  • Florida Clinical Trials Group - Tamarac

    Tamarac, Florida, 33321

    Recruiting

Other trials in United States

Australia6 sites, 6 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, 3199

    Recruiting

  • Peninsula and Southeast Oncology (PASO) Medical

    Frankston, Victoria

    Recruiting

  • GenesisCare North Shore (Oncology)

    Saint Leonards, New South Wales

    Not yet recruiting

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales

    Recruiting

Other trials in Australia

Spain4 sites, 4 recruiting

  • START - Barcelona

    Barcelona, 08023

    Recruiting

  • START Rioja - Hospital de San Pedro

    Logroño, 26006

    Recruiting

  • NEXT Madrid HUQSM

    Madrid, 28233

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Poland3 sites, 3 recruiting

  • GCPMED Sp. z o.o., Centrum Medyczne iMed24

    Krakow, 31-864

    Recruiting

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, 90-338

    Recruiting

  • One Day Med

    Szczecin, West Pomeranian Voivodeship, 70-419

    Recruiting

Other trials in Poland

New Zealand2 sites, 2 recruiting

  • Palmerstone North Hospital

    Roslyn, Manawatu, 4414

    Recruiting

  • Health New Zealand

    Wellington

    Recruiting

Other trials in New Zealand

Portugal2 sites, 2 recruiting

  • Hospital de Santa Maria

    Lisbon, 1649-028

    Recruiting

  • Unidade Local de Saúde (ULS) Loures Odivelas

    Loures, 2674-514

    Recruiting

Other trials in Portugal

Austria1 site, 1 recruiting

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020

    Recruiting

Other trials in Austria

Belgium1 site, 1 recruiting

  • Centre Hospitalier Universitaire Brugmann - Victor Horta

    Brussels, 1020

    Recruiting

Other trials in Belgium

Finland1 site, 1 recruiting

  • Kuopio University Hospital

    Kuopio, 70210

    Recruiting

Other trials in Finland

Germany1 site, 1 recruiting

  • Norddeutsches Studienzentrum fur Innovative Onkologie (NIO) Hamatologisch Onkologische Praxis Eppendorf (HOPE)

    Hamburg, 22297

    Recruiting

Other trials in Germany

Italy1 site, 1 recruiting

  • Campus Bio-Medico di Rome University

    Rome, 00128

    Recruiting

Other trials in Italy

Norway1 site, 1 recruiting

  • Oslo University

    Oslo, 0379

    Recruiting

Other trials in Norway

Singapore1 site, 1 recruiting

  • National Cancer Centre Singapore (NCCS)

    Singapore, Central Region, 168583

    Recruiting

Other trials in Singapore

South Korea1 site, 1 recruiting

  • Ajou University School of Medicine & Graduate School of Medicine

    Suwon, 16499

    Recruiting

Other trials in South Korea

About this study

Official title: 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

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.

Read the detailed description

This Phase 1/2 study (EIK1005-002) will investigate the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of EIK1005 as a monotherapy and in combination with pembrolizumab in participants with advanced solid tumors, including participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors.

The study will be conducted in 2 parts: Part 1 and Part 2, with Part 1 being further divided into Part 1A and Part 1B as described below:

  • Part 1A (monotherapy dose escalation): participants will receive EIK1005 only.
  • Part 1B (combination dose escalation): participants will receive EIK1005 in combination with pembrolizumab.
  • Part 2 (dose optimization): participants will be randomized 1:1 to monotherapy with EIK1005 at one of the two selected doses from Part 1A to identify the dose of EIK1005 in monotherapy for subsequent studies.
Being tested
EIK1005, pembrolizumab (KEYTRUDA® )
Keywords
Werner helicase, WRN, MSI-H, dMMR, DNA mismatch repair, EIK1005, Advanced Solid Tumors, Metastatic, MSI-H/dMMR Endometrial Cancer, MSI-H/dMMR Prostate Cancer, Pembrolizumab, Mismatch Repair Deficient (dMMR), Microsatellite Instability High (MSI-H)
Medical subject headings
Endometrial Neoplasms, Turcot syndrome, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EIK1005Drug

    EIK1005 is a selective inhibitor of the Werner helicase.

  • pembrolizumab (KEYTRUDA® )Drug

    Pembrolizumab is a PD-1 inhibitor.

Study groups in NCT07262619
Study groupRoleWhat they receive
Part 1A (Dose escalation, Monotherapy)ExperimentalEIK1005 will be given as monotherapy in participants without alternative treatment options.
Receives: Drug: EIK1005
Part 1B (Dose escalation, Combination with pembrolizumab)ExperimentalEIK1005 will be given in combination with pembrolizumab to participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) solid tumors.
Receives: Drug: EIK1005; Drug: pembrolizumab (KEYTRUDA® )
Part 2 (Dose optimization, Monotherapy)ExperimentalParticipants 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.
Receives: Drug: EIK1005

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicity (DLT) - Part 1

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

    Measured: 21 Days

  2. Adverse Events (AEs) - Part 1 and Part 2

    Number of participants reporting adverse events or serious adverse events.

    Measured: From the time of first dose of study medication through 30 days following cessation of study treatment.

Secondary outcomes (9)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Through study completion, an average of 2 years.

  5. Pharmacokinetic (PK) parameters of EIK1005 - AUC0-24 (Part 1 and Part 2)

    AUC0-24 (Area Under the plasma Concentration versus time curve from 0 to 24 hours): Measures total drug exposure over the first 24 hours after dosing of EIK1005 as monotherapy and in combination with pembrolizumab.

    Measured: Up to 1 year

  6. Pharmacokinetic (PK) parameters of EIK1005 - AUCtau,ss (Part 1 and Part 2)

    AUCtau,ss [Area Under the plasma Concentration versus time curve over one dosing interval (tau) at steady state]: Reflects average drug exposure during each dosing interval once the steady state has been reached for EIK1005 as monotherapy and in combination with pembrolizumab.

    Measured: Up to 1 year

  7. Pharmacokinetic (PK) parameters of EIK1005 - Cmax (Part 1 and Part 2)

    Cmax (Maximum Plasma Concentration) after dose administration of EIK1005 as monotherapy and in combination with pembrolizumab.

    Measured: Up to 1 year

  8. Pharmacokinetic (PK) parameters of EIK1005 - tmax (Part 1 and Part 2)

    tmax (the time required for the plasma concentration of the drug to reach maximum concentration after dose administration) of EIK1005 as monotherapy and in combination with pembrolizumab.

    Measured: Up to 1 year

  9. Pharmacokinetic (PK) parameters of EIK1005 - t½ (Half-life) (Part 1 and Part 2)

    Half-life (the time required for the plasma concentration of the drug to decrease by 50% after the dose administration) of EIK1005 as monotherapy and in combination with pembrolizumab.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start20 Jan 2026
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07262619
Sponsor's protocol ID
EIK1005-002
Other IDs
2026-525248-13-00, KEYNOTE-G56, MK-3475-G56
Status last verified
Sep 2026
First submitted
10 Nov 2025
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EIK1005 and pembrolizumab (KEYTRUDA® ) in people with Advanced Solid Tumors and MSI-H or dMMR Advanced Solid Tumors, run by Eikon Therapeutics at 35 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Australia, Spain, Poland, New Zealand and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ana C Mamede, PharmD (347-806-4584, mamedea@eikontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) - Part 1 (time frame: 21 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07262619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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