EIK1004 BIS-TARTRATE for Advanced solid tumors | Endometrioid epithelial ovarian cancer | Fallopian tube cancer | Primary peritoneal cancer | HER2-negative breast cancer | Metastatic castration-resistant prostate cancer | Metastatic pancreatic ductal adenocarcinoma

Inclusion criteria

• {"criterion_text":"- 1. Participants must voluntarily participate and comply with study procedures\n- 10. Female Participants should meet ≥ 1 of the following: a. Lack of childbearing potential b. Post-menopausal c. For those with childbearing potential, have a negative pregnancy test at screening, not be in lactation, and willing to take highly effective contraceptive\n- 11. Male participants had a vasectomy or use highly effective methods of (from day-0 to 6 months after last dose of IMP)\n- 12. For PARPi-treated participants, up to 1 prior nonselective PARPi-containing treatment (treatment or maintenance) is allowed (Part 1 only).\n- C NS Inclusion (Backfill Cohort): Participants must have one of the following:\n- 13. Untreated CNS Metastases.\n- 14. Previously treated CNS Metastases: a. Screening MRI must show no lesion increase >10 mm in 4 weeks b. Participants with new CNS lesions treated during Screening may enroll if: •\tWBRT >28 days, SRS >14 days, or surgery >28 days before first treatment dose. •\tNon-CNS sites of evaluable disease are present.\n- 2. Participants must be ≥ 18 years of age\n- 3. Participants must have 1 of the following: a. Confirmed advanced/recurrent/metastatic, endometrioid EOC, fallopian tube or primary peritoneal cancer (Cohorts-1A/C, Pt2/3), and: i. Must received ≥ 1 prior chemotherapy for advanced disease ii. Should have evaluable disease as defined: a. ≥ 1 measurable lesion per RECIST v1.1 and/or b. CA125 evaluable b. Confirmed advanced/recurrent/metastatic HER2-neg adenocarcinoma of the breast and (Pt 1 and 2): i. Must have received ≥ 1 prior chemotherapy ii. Participants with HR+ must have received hormonal therapy iii. Should have evaluable disease defined as ≥ 1 measurable lesion c. Confirmed adenocarcinoma of mCRPC (Pt1): i. mCRPC: With ongoing ADT within 28 days before study start. Participants receiving ADT should continue treatment during the study ii. Prior therapies: a. Must have received a novel hormonal agent b. Must have received up to 1 prior taxane based chemotherapy/ineligible for chemotherapy iv. Should have evaluable disease defined as: a) ≥ 1 measurable lesion per RECIST v1.1, AND/OR b) ≥ 1 evaluable lesion documented by positive bone scan c) PSA evaluable defined as a serum PSA ≥ 1 ng/mL during screening based on prostate working group 3 criteria. d) Histologically/cytologically confirmed advanced/recurrent/ mPDAC (Part 1) i. Must have received an appropriate prior regimen per Investigator ii. Should have evaluable disease defined as ≥ 1 measurable lesion per RECIST v1.1\n- 4. Participants are required to have deleterious or suspected deleterious germline or somatic mutations of one of the following genes: BRCA1, BRCA2, PALB2, RAD51B, RAD51C or RAD51D.\n- 5. Participants with evaluable disease must have documented radiological progressive cancer before study entry.\n- 6. For prostate cancer, PSA progression per PCWG3 is acceptable (Part 1)\n- 7. ECOG Performance Status of 0 to 1\n- 8. Life expectancy must be ≥ 12 weeks\n- 9. Have adequate organ function"}

Exclusion criteria

• {"criterion_text":"- 1. Any participants treated with anti-cancer therapies\n- 10. Participants with a diagnosis of MDS or AML or have received transplantation.\n- 11.Participants with any known predisposition to bleeding.\n- 12. Live/attenuated vaccine within 28 days prior to the 1st dose of IMP\n- 13. COVID-19 vaccine within 72 hours prior to 1st dose of IMP\n- 14. Participants with administration of any strong inhibitors/inducers of CYP3A4 or P-gp inhibitors within 28 days or 5 half-lives (whichever is shorter) prior to the 1st dose of the IMP\n- 15. Participants who may need continuous treatment with PPIs or P-CABs or H2-blockers during the study period\n- 16. Participants with a known history of hypersensitivity to the study drug or any of its excipients.\n- 17. Participants who are unable to swallow oral medications,\n- 18. Female participants who are pregnant or lactating/breastfeeding.\n- 19. Participants known to have a history of alcoholism or drug abuse\n- 2. Participants that received prior PARP1-selective inhibitors\n- 20. Participants who have participated in another clinical study with an investigational product administered in the last 28 days\n- 21.Have used an investigational device within 28 days prior to the first dose of study drug.\n- 22.Participants with active or untreated CNS metastases and/or carcinomatous meningitis based on Screening brain MRI (Pt1 & 2)\n- C NS Exclusion (Backfill):\n- 23. Any untreated brain lesions > 2.0 cm in size.\n- 24. Ongoing use of systemic corticosteroids to control symptoms of CNS metastases.\n- 25. Any Brain lesion requiring immediate local therapy\n- 26.Known symptomatic leptomeningeal disease.\n- 27. Have poorly controlled seizures.\n- 3. Participants who have undergone: major surgery, extensive field radiotherapy, palliative radiotherapy OR used a radioactive drug\n- 4. Participants with other malignancies requiring treatment within 2 years before 1st dose of IMP\n- 5. Participants previous treatment-related toxicities that have not recovered, i.e., to ≤ Grade 1, as evaluated by NCI-CTCAE or baseline (Grade 2 and other non clinically significant toxicities can be enrolled)\n- 6. Participants with any of the following cardiac criteria: a. mean resting QTcF > 470 ms b. any factors that increase the risk of QT prolongation, or use of concomitant drugs that may prolong/shorten QT and at risk of Torsades de Pointes; c. any clinically important abnormalities of resting ECG\n- 7. Participants with other cardiovascular diseases as defined by any of the following: a. symptomatic heart failure b. uncontrolled hypertension c. hypertensive heart disease d. acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure e. cardiomyopathy f. presence of clinically significant valvular heart disease g. history of arrhythmia requiring treatment; Participants with atrial fibrillation and optimally controlled ventricular rate are permitted h. transient ischemic attack or stroke within 6 months prior to Screening i.participants with symptomatic hypotension at Screening\n- 8. Participants with infections, including: a. An uncontrolled acute infection, an active infection requiring systemic treatment, prophylactic use of systemic antibiotics is allowed b. HIV-infected participants must have well-controlled HIV and be on ART defined as: i. must have a CD4+ T-cell count ≥ 350 cells/mm3 at screening, ii. must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the LLOQ iii. must not have had any AIDS-defining opportunistic infections within the past 12 months, iv. must have been on a stable regimen for at least 4 weeks before study entry and agree to continue ART throughout the study, v. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors/inducers/substrates c. A known active Hep B/C infection d. Active tuberculosis\n- 9. Any major illness that will substantially increase the risk associated with the patient’s participation in this study"}

Primary endpoints

• {"endpoint_text":"- • Dose-limiting toxicities (DLTs)\n- • Adverse events (AEs)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- • PK parameters derived from plasma concentration data of EIK1004 and/or metabolites (if applicable) following single oral dose\n- • PK parameters derived from plasma concentration data of EIK1004 and/or metabolites (if applicable) following multiple oral doses\n- • Objective Response (OR)\n- • Disease Control (DC)\n- • Duration of Response (DOR)\n- • Time to response (TTR)\n- • Percentage change from Baseline in sum of target lesions.\n- • Clinical benefit (CB)\n- • Time to CNS progression","definition_or_measurement_approach":"PK endpoints: derived from plasma concentration data of EIK1004 and/or metabolites following single and multiple oral doses. Other endpoints: measurement approaches not specified in the provided record."}

France

Earliest CTIS Part Ii Submission Date

05-06-2025

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

56

Number Of Sites

5

Number Of Participants

10

Portugal

Earliest CTIS Part Ii Submission Date

01-07-2025

Latest Decision Or Authorization Date

14-07-2025

Processing Time Days

13

Number Of Sites

4

Number Of Participants

16

Spain

Earliest CTIS Part Ii Submission Date

02-07-2025

Latest Decision Or Authorization Date

16-07-2025

Processing Time Days

14

Number Of Sites

9

Number Of Participants

10

Denmark

Earliest CTIS Part Ii Submission Date

30-06-2025

Latest Decision Or Authorization Date

14-07-2025

Processing Time Days

14

Number Of Sites

1

Number Of Participants

6

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

sponsorDuties codes: 12, 4, 5; contact email: CTIS-Biotech@iconplc.com

Name

Novotech Laboratory Services (Taiwan) Co. Ltd.

Responsibilities

Laboratory services; sponsorDuties code: 4; contact email: communications@novotech-cro.com

Name

Natera Inc.

Responsibilities

Laboratory/testing responsibilities; sponsorDuties code: 4; contact email: PharmaClinicalTrials@natera.com

Third parties

• {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"sponsorDuties codes: 4; contact email: Client.services@foundationmedicine.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"sponsorDuties codes: 4; contact email: Client.services@foundationmedicine.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Natera Inc. (Austin)","duties_or_roles":"sponsorDuties codes: 4; contact email: PharmaClinicalTrials@natera.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Taiwan","full_name":"Novotech Laboratory Services (Taiwan) Co. Ltd.","duties_or_roles":"sponsorDuties codes: 4; contact email: communications@novotech-cro.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"sponsorDuties codes: 8; contact email: oracle_ema_enquiries_grp@oracle.com","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 12, 4, 5; contact email: CTIS-Biotech@iconplc.com","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"sponsorDuties codes: 14; contact email: GMB-PS-SCH-CSS-QP@catalent.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Natera Inc. (San Carlos)","duties_or_roles":"sponsorDuties codes: 4; contact email: support@natera.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"sponsorDuties code: 15; value: Diaries, Patient Reported Outcomes; contact email: deanna@medable.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties code: 15; value: Patient Reimbursements; contact email: clientcompliance@meetingprotocol.com","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes include eConsent, RTSM (values provided); contact email: contact@veeva.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Scisafe Inc.","duties_or_roles":"sponsorDuties code: 15; value: Long term storage of samples; contact email: tclem@scisafe.com","organisation_type":"Pharmaceutical company"}