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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eikon Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-05-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Eikon Therapeutics, Inc.

External identifiers

EU CT number

2026-525248-13-00

ClinicalTrials.gov

NCT07262619

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Therapy, Pharmacodynamic, Pharmacokinetic

1. To evaluate the safety and tolerability of EIK1005 as monotherapy or in combination with pembrolizumab to determine the MTD (or MAD) of EIK1005 (Part 1).

2. To evaluate the safety and tolerability of EIK1005 for dose optimization (Part 2).

Secondary objectives 3

1. 1. To evaluate the preliminary antitumor activity of EIK1005 monotherapy or in combination with pembrolizumab (Part 1).
2. 2. To evaluate the preliminary antitumor activity of EIK1005 for dose optimization (Part 2)
3. 3. To characterize the plasma PK profile of EIK1005 as monotherapy and in combination with pembrolizumab (Part 1 and Part 2).

Conditions and MedDRA coding

Advanced Solid Tumors

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Participants are eligible to be included in the study only if all of the following criteria apply, and the participant: 1. is ≥ 18 years of age at the time of signing the informed consent.
2. 2. has a life expectancy of at least 3 months.
3. 3. has histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor. a. Part 1A: recommend that participants have archival tissue not more than 3 years old. b. Part 1B and Part 2: participant has locally confirmed MSI-H or 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. 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 CPI therapy and (2) participants with MSS cancers that have progressed following at least one regimen of platinum, alkylating or topoisomerase containing chemotherapy.
5. 5. has measurable disease at baseline according to RECIST 1.1 as determined by the PI
6. 6. has an ECOG score of 0 to 1.
7. 7. has an adequate organ and marrow function.

Exclusion criteria 11

1. A participant is excluded from the study if any of the following criteria apply: 1. has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy induced AEs.
2. 2. has received prior treatment with WRN inhibitor.
3. 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. 4. In Parts 1B: 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. 5. has known additional malignancy that is progressing or has required active treatment within the past 3 years.
6. 6. has known active 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. 7. has mean resting QTcF > 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs).
8. 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. 9. has history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
10. 10. has active tuberculosis.
11. 11. has any active infections requiring systemic therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. DLTs & AEs
2. 2. AEs

Secondary endpoints 8

1. 1. OR (defined as participants who have a CR or PR) by RECIST 1.1 as assessed by the Investigator.
2. 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.
3. 3. DC (defined as participants with a BOR of CR, PR, or SD) by RECIST 1.1 as assessed by the Investigator.
4. 4. OR
5. 5. DOR
6. 6. DC
7. 7. 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).
8. 8. PK parameters derived from plasma concentrations of EIK1005, following multiple doses, including but not limited to: • AUC0-24, AUCtau,ss, Cmax, t1/2, tmax, Rac-Cmax, RacAUC

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eikon Therapeutics Inc.

Sponsor organisation

Eikon Therapeutics Inc.

Address

3 2nd Street Floor 4

City

Jersey

Postcode

07311-4045

Country

United States

Scientific contact point

Organisation

Eikon Therapeutics Inc.

Contact name

Nilou Mobashery

Public contact point

Organisation

Eikon Therapeutics Inc.

Contact name

Aish Movva

Third parties 6

Locations

8 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 56 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications