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.

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]

Trial duration

12 Aug 2025 → ongoing

Decision date (initial)

2025-07-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Eikon Therapeutics, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacogenetic, Dose response, Pharmacokinetic, Efficacy, Pharmacodynamic, Safety

• 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)

Secondary objectives 3

1. • To characterize the plasma pharmacokinetic (PK) profile of single and multiple doses of EIK1004 (Part 1 and Part 2).
2. • To assess preliminary antitumor activity of EIK1004 as monotherapy (Part 1).
3. • To assess preliminary antitumor activityof EIK1004 as monotherapy (Part 2).

Conditions and MedDRA coding

Advanced solid tumors

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. 1. Participants must voluntarily participate and comply with study procedures
2. 2. Participants must be ≥ 18 years of age
3. 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
4. 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.
5. 5. Participants with evaluable disease must have documented radiological progressive cancer before study entry.
6. 6. For prostate cancer, PSA progression per PCWG3 is acceptable (Part 1)
7. 7. ECOG Performance Status of 0 to 1
8. 8. Life expectancy must be ≥ 12 weeks
9. 9. Have adequate organ function
10. 10. 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
11. 11. Male participants had a vasectomy or use highly effective methods of (from day-0 to 6 months after last dose of IMP)
12. 12. For PARPi-treated participants, up to 1 prior nonselective PARPi-containing treatment (treatment or maintenance) is allowed (Part 1 only).
13. CNS Inclusion (Backfill Cohort): Participants must have one of the following:
14. 13. Untreated CNS Metastases.
15. 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: • WBRT >28 days, SRS >14 days, or surgery >28 days before first treatment dose. • Non-CNS sites of evaluable disease are present.

Exclusion criteria 28

1. 1. Any participants treated with anti-cancer therapies
2. 2. Participants that received prior PARP1-selective inhibitors
3. 3. Participants who have undergone: major surgery, extensive field radiotherapy, palliative radiotherapy OR used a radioactive drug
4. 4. Participants with other malignancies requiring treatment within 2 years before 1st dose of IMP
5. 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)
6. 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
7. 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
8. 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
9. 9. Any major illness that will substantially increase the risk associated with the patient’s participation in this study
10. 10. Participants with a diagnosis of MDS or AML or have received transplantation.
11. 11.Participants with any known predisposition to bleeding.
12. 12. Live/attenuated vaccine within 28 days prior to the 1st dose of IMP
13. 13. COVID-19 vaccine within 72 hours prior to 1st dose of IMP
14. 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
15. 15. Participants who may need continuous treatment with PPIs or P-CABs or H2-blockers during the study period
16. 16. Participants with a known history of hypersensitivity to the study drug or any of its excipients.
17. 17. Participants who are unable to swallow oral medications,
18. 18. Female participants who are pregnant or lactating/breastfeeding.
19. 19. Participants known to have a history of alcoholism or drug abuse
20. 20. Participants who have participated in another clinical study with an investigational product administered in the last 28 days
21. 21.Have used an investigational device within 28 days prior to the first dose of study drug.
22. 22.Participants with active or untreated CNS metastases and/or carcinomatous meningitis based on Screening brain MRI (Pt1 & 2)
23. CNS Exclusion (Backfill):
24. 23. Any untreated brain lesions > 2.0 cm in size.
25. 24. Ongoing use of systemic corticosteroids to control symptoms of CNS metastases.
26. 25. Any Brain lesion requiring immediate local therapy
27. 26.Known symptomatic leptomeningeal disease.
28. 27. Have poorly controlled seizures.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. • Dose-limiting toxicities (DLTs)
2. • Adverse events (AEs)

Secondary endpoints 9

1. • PK parameters derived from plasma concentration data of EIK1004 and/or metabolites (if applicable) following single oral dose
2. • PK parameters derived from plasma concentration data of EIK1004 and/or metabolites (if applicable) following multiple oral doses
3. • Objective Response (OR)
4. • Disease Control (DC)
5. • Duration of Response (DOR)
6. • Time to response (TTR)
7. • Percentage change from Baseline in sum of target lesions.
8. • Clinical benefit (CB)
9. • Time to CNS progression

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eikon Therapeutics Inc.

Sponsor organisation

Eikon Therapeutics Inc.

Address

450 East 29th Street Floor 15th

City

New York

Postcode

10016-8367

Country

United States

Scientific contact point

Organisation

Eikon Therapeutics Inc.

Contact name

Viola Chen

Public contact point

Organisation

Eikon Therapeutics Inc.

Contact name

Surya Vangala

Third parties 12

Locations

4 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 25 files

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

Application history

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