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EIK1005

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Eikon Therapeutics, Inc.|Last Updated: Apr 8, 2026

Target and mechanism

Molecular targetWRN
Target classHelicase
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

EIK1005 · 1 trial · 7 indications

Phase 1 1
NCT07262619EIK1005-002: 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) TumorsAdvanced Solid Tumors
RECRUITING160 Analytics
PHASE1RECRUITING
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
Advanced Solid Tumors
NCT07262619160
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Study Endpoints

Primary Endpoints

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.

Secondary Endpoints

Objective Response (OR) - Part 1 and Part 2
Through study completion, an average of 2 years.
Duration of Response (DOR) - Part 1 and Part 2
Through study completion, an average of 2 years.
Disease Control (DC) - Part 1 and Part 2
Through study completion, an average of 2 years.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A (Dose escalation, Monotherapy)EXPERIMENTALEIK1005 will be given as monotherapy in participants without alternative treatment options.
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.
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.

Interventions

NameTypeDescription
EIK1005DRUGEIK1005 is a selective inhibitor of the Werner helicase.
pembrolizumab (KEYTRUDA® )DRUGPembrolizumab is a PD-1 inhibitor.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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 tis...

Countries:United StatesAustraliaNew Zealand
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about EIK1005

What is EIK1005 used for in advanced solid tumors?

EIK1005 is an investigational small molecule being developed for the treatment of advanced solid tumors, including microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) tumors. It is being studied as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, including gastric, colorectal, gastroesophageal-junction, and endometrial cancers.

What does EIK1005 target?

EIK1005 targets WRN, a helicase enzyme. As a Werner helicase inhibitor, it is designed to interfere with the function of the WRN protein, which plays a role in DNA replication and repair. This mechanism is being investigated for its potential antitumor activity in advanced solid tumors, particularly those with microsatellite instability.

Who is developing EIK1005?

EIK1005 is being developed by Eikon Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of EIK1005 in patients with advanced solid tumors.

What phase is EIK1005 in?

EIK1005 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 study is recruiting participants to evaluate EIK1005 as a monotherapy and in combination with pembrolizumab.

What clinical trials is EIK1005 in?

EIK1005 is being studied in a Phase 1 clinical trial with the identifier NCT07262619. This study, titled EIK1005-002, is evaluating EIK1005 as a monotherapy and in combination with pembrolizumab in participants with advanced solid tumors, including MSI-H or dMMR tumors. The trial is recruiting up to 160 participants in the United States, Australia, and New Zealand.

Is EIK1005 the same as a Werner helicase inhibitor?

Yes, EIK1005 is a Werner helicase inhibitor. It targets the WRN helicase enzyme, which is involved in DNA metabolism. This mechanism is being investigated for the treatment of advanced solid tumors, particularly those with microsatellite instability high or mismatch repair deficient status.