EIK1005 SODIUM for Advanced solid tumors

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 2. has a life expectancy of at least 3 months."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 5. has measurable disease at baseline according to RECIST 1.1 as determined by the PI"}
• {"criterion_text":"- 6. has an ECOG score of 0 to 1."}
• {"criterion_text":"- 7. has an adequate organ and marrow function."}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 10. has active tuberculosis."}
• {"criterion_text":"- 11. has any active infections requiring systemic therapy"}
• {"criterion_text":"- 2. has received prior treatment with WRN inhibitor."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 5. has known additional malignancy that is progressing or has required active treatment within the past 3 years."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 7. has mean resting QTcF > 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs)."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 9. has history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease"}

Primary endpoints

• {"endpoint_text":"- 1. DLTs & AEs","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2. AEs","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 1. OR (defined as participants who have a CR or PR) by RECIST 1.1 as assessed by the Investigator.","definition_or_measurement_approach":"OR defined as participants who have a CR or PR by RECIST 1.1 as assessed by the Investigator."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"DOR defined as time from first documented CR or PR until disease progression or death (whichever occurs first) in participants with CR or PR, assessed by RECIST 1.1 by Investigator."}
• {"endpoint_text":"- 3. DC (defined as participants with a BOR of CR, PR, or SD) by RECIST 1.1 as assessed by the Investigator.","definition_or_measurement_approach":"DC defined as participants with a best overall response (BOR) of CR, PR, or SD by RECIST 1.1 as assessed by the Investigator."}
• {"endpoint_text":"- 4. OR","definition_or_measurement_approach":""}
• {"endpoint_text":"- 5. DOR","definition_or_measurement_approach":""}
• {"endpoint_text":"- 6. DC","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"PFS defined as time from randomization to first documented progression by RECIST 1.1 or death (whichever occurs first), assessed by Investigator."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"PK parameters from plasma concentrations after multiple doses including AUC0-24, AUCtau,ss, Cmax, t1/2, tmax, Rac-Cmax, RacAUC."}

Austria

Latest Decision Or Authorization Date

12-05-2026

Finland

France

Latest Decision Or Authorization Date

31-03-2026

Germany

Latest Decision Or Authorization Date

07-05-2026

Italy

Latest Decision Or Authorization Date

15-05-2026

Spain

Norway

Earliest CTIS Part Ii Submission Date

24-04-2026

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

21

Number Of Sites

1

Number Of Participants

5

Poland

Primary sponsor

Full Name

Eikon Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

CRO

Third parties

• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"eDiary and eCOA","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"eTMF","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}