2024-520395-99-00RecruitingPhase 2
A Phase 1/2, open-label, multicenter, dose-escalation, and dose‑optimization study to evaluate the safety, tolerability, and activity of EIK1004 (IMP1707) as monotherapy in participants with advanced solid tumors.
Eikon Therapeutics Inc.19 sites in 4 countries42 target enrollmentStarted: July 14, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Eikon Therapeutics Inc.
- Enrollment
- 42
- Locations
- 19
- Primary Endpoint
- • Dose-limiting toxicities (DLTs)
Study Overview
Brief Summary
• To evaluate the safety and tolerability of EIK1004 as monotherapy to determine the MTD (or MAD) and RDE as monotherapy (Part 1) • To evaluate the safety and tolerability of EIK1004 as monotherapy (Part 2)
Study Design
- Allocation
- Randomized
- Primary Purpose
- Part 2 Dose Optimization
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants must voluntarily participate and comply with study procedures
- •Female Participants should meet ≥ 1 of the following criteria: 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
- •Male participants had a vasectomy or use highly effective methods of (from day-0 to 6 months after last dose of IMP)
- •For PARPi-treated participants, up to 1 prior nonselective PARPi-containing treatment (treatment or maintenance) is allowed (Part 1 only).
- •CNS Inclusion (Backfill Cohort): Participants must have one of the following:
- •Untreated CNS Metastases.
- •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: • WBRT >28 days, SRS >14 days, or surgery >28 days before first treatment dose. • Non-CNS sites of evaluable disease are present.
- •Participants must be ≥ 18 years of age
- •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
- •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.
- •Participants with evaluable disease must have documented radiological progressive cancer before study entry.
- •For prostate cancer, PSA progression per PCWG3 is acceptable (Part 1)
- •ECOG Performance Status of 0 to 1
- •Life expectancy must be ≥ 12 weeks
- •Have adequate organ function
Exclusion Criteria
- •Any participants treated with anti-cancer therapies
- •Participants with a diagnosis of MDS or AML or have received transplantation.
- •11.Participants with any known predisposition to bleeding.
- •Live/attenuated vaccine within 28 days prior to the 1st dose of IMP
- •COVID-19 vaccine within 72 hours prior to 1st dose of IMP
- •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
- •Participants who may need continuous treatment with PPIs or P-CABs or H2-blockers during the study period
- •Participants with a known history of hypersensitivity to the study drug or any of its excipients.
- •Participants who are unable to swallow oral medications,
- •Female participants who are pregnant or lactating/breastfeeding.
- •Participants known to have a history of alcoholism or drug abuse
- •Participants that received prior PARP1-selective inhibitors
- •Participants who have participated in another clinical study with an investigational product administered in the last 28 days
- •21.Have used an investigational device within 28 days prior to the first dose of study drug.
- •22.Participants with active or untreated CNS metastases and/or carcinomatous meningitis based on Screening brain MRI (Pt1 & 2)
- •CNS Exclusion (Backfill):
- •Any untreated brain lesions > 2.0 cm in size.
- •Ongoing use of systemic corticosteroids to control symptoms of CNS metastases.
- •Any Brain lesion requiring immediate local therapy
- •26.Known symptomatic leptomeningeal disease.
- •Have poorly controlled seizures.
- •Participants who have undergone: major surgery, extensive field radiotherapy, palliative radiotherapy OR used a radioactive drug
- •Participants with other malignancies requiring treatment within 2 years before 1st dose of IMP
- •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)
- •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
- •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
- •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
- •Any major illness that will substantially increase the risk associated with the patient’s participation in this study
Outcomes
Primary Outcomes
• Dose-limiting toxicities (DLTs)
• Dose-limiting toxicities (DLTs)
• Adverse events (AEs)
• Adverse events (AEs)
Secondary Outcomes
- • Time to response (TTR)
- • Time to CNS progression
- • Percentage change from Baseline in sum of target lesions.
- • Clinical benefit (CB)
- • PK parameters derived from plasma concentration data of EIK1004 and/or metabolites (if applicable) following single oral dose
- • PK parameters derived from plasma concentration data of EIK1004 and/or metabolites (if applicable) following multiple oral doses
- • Objective Response (OR)
- • Disease Control (DC)
- • Duration of Response (DOR)
Investigators
Viola Chen
Scientific
Eikon Therapeutics Inc.
Study Sites (19)
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