Recruiting
Phase 1
Phase 2

EIK1004

Sponsor:

Eikon Therapeutics

Code:

NCT06907043

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

EIK1004-001 (IMP1707-001)

Study Details

Brief summary:

This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/metastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer (mCRPC) and pancreatic cancer with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes.

Condition or disease Intervention/treatment Phase Advanced Solid Tumors Drug: EIK1004 (IMP1707) Phase 1/Phase 2

Conditions

Advanced Solid Tumors

Study ID

NCT06907043

Start date

Apr 30, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

• Breast cancer: must have received at least one prior chemotherapy in neoadjuvant/adjuvant/metastatic setting, must have received hormonal therapy if HR+, HGSOC or high grade endometrioid EOC, fallopian tube or primary peritoneal cancer; must have received at least one prior platinum-based chemotherapy for advanced disease.

mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane chemotherapy; Pancreatic cancer, must have prior 1L therapy

  • Age ≥ 18 years at the time of informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Adequate organ function
  • Life expectancy ≥ 12 weeks
  • Should have evaluable disease as defined by RECIST1.1 and/or CA125 or PSA
  • Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception from study entry up to 6 months after the last dose of EIK1004 (IMP1707)
  • Deleterious or suspected deleterious germline or somatic mutations of select HRR genes
  • Up to 1 prior line of PARP inhibitor containing treatment

CNS Inclusion Criteria:

  • Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy.
  • Previously treated CNS metastases

Key Exclusion Criteria:

  • Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of EIK1004 (IMP1707)
  • Have received prior PARP1 selective inhibitors
  • Mean resting QTcF > 470 ms or QTcF < 340 ms
  • Infections

\- An active hepatitis B/C infection
  • Any known predisposition to bleeding
  • Unable to swallow oral medications OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair the bioavailability

CNS Exclusion Criteria

  • Any untreated brain lesions > 2.0 cm in size.
  • Ongoing use of systemic corticosteroids for control of symptoms of CNS metastases < 7 days prior to the first dose of study treatment or requirement for > 10 mg prednisone/day.
  • Any brain lesion requiring immediate local therapy, including (but not limited to) a lesion in an anatomic site where an increase in size or possible treatment-related edema may pose risk to the participant (eg, brain stem lesions).
  • Known, symptomatic leptomeningeal disease.
  • Have poorly controlled seizures.

Study Design

Enrollment

130 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1

EIK1004 (IMP1707) monotherapy; oral tablet(s) daily (except for the single-dose period). Participants will receive escalating doses of EIK1004 (IMP1707) until progressive disease or discontinuation.

Interventions

EIK1004-001 (IMP1707-001)

PARP1 selective inhibitor

Primary outcome measure

  • Number of Participants who experience a Dose-Limiting Toxicity (DLT) [ Time Frame: (Timeframe: up to 28 days) ]
  • Number of participants with adverse events, treatment emergent adverse events or serious adverse events [ Time Frame: (Time Frame: 1 month post last dose of EIK1004 (IMP1707) ]

Central Contacts and Locations

Central contacts

Locations

Sarah Cannon Research Institute at HealthOne

Recruiting

Denver, Colorado, United States, 80218

Contacts

Florida Cancer Center

Recruiting

Lake Mary, Florida, United States, 32746

Contacts

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

More Information

Sponsor

Eikon Therapeutics

Last update posted

Aug 19, 2025

Last verified

Aug, 2025

Keywords

  • EIK1004
  • IMP1707
  • Advanced/recurrent/metastatic pancreatic adenocarcinoma
  • Brain metastases
  • Advanced HER2-negative breast adenocarcinoma
  • Recurrent HER2-negative breast adenocarcinoma
  • metastatic HER2-negative breast adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eikon Therapeutics on 2025-08-19.