Status:
RECRUITING
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
Lead Sponsor:
Eikon Therapeutics
Collaborating Sponsors:
Impact Therapeutics, Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-89 years
Phase:
PHASE1
PHASE2
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 r...
Detailed Description
This study will evaluate the safety, tolerability and preliminary efficacy of EIK1004 (IMP1707) as monotherapy in patients with recurrent, advanced/metastatic solid tumors. The study consists of 2 par...
Eligibility Criteria
Inclusion
- • 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
- Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy.
- Previously treated CNS metastases
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06907043
Start Date
April 30 2025
End Date
December 1 2028
Last Update
August 19 2025
Active Locations (10)
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1
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States, 80218
2
Florida Cancer Center
Lake Mary, Florida, United States, 32746
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
MD Anderson
Houston, Texas, United States, 77030