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A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
NCT06907043 · Eikon Therapeutics
In plain English
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Official title
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
About this study
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 parts: Dose escalation and dose optimization.
In dose escalation (Part1), the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor.
In dose optimization (Part 2), the study will further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of EIK1004 (IMP1707)
Eligibility criteria
• 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 target: 130 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-30
Estimated completion: 2028-12
Last updated: 2025-08-19
Interventions
Drug: EIK1004-001 (IMP1707-001)
Primary outcomes
- • Number of Participants who experience a Dose-Limiting Toxicity (DLT) ((Timeframe: up to 28 days))
- • Number of participants with adverse events, treatment emergent adverse events or serious adverse events ((Time Frame: 1 month post last dose of EIK1004 (IMP1707))
Sponsor
Eikon Therapeutics · industry
With: Impact Therapeutics, Inc.
Contacts & investigators
ContactSunny Chaudry, MS · contact · chaudrys@eikontx.com · 6319026200
InvestigatorYawei Zhang, MD · study_director, Eikon Therapeutics
All locations (10)
Sarah Cannon Research Institute at HealthOneRecruiting
Denver, Colorado, United States
Florida Cancer CenterRecruiting
Lake Mary, Florida, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
MD AndersonRecruiting
Houston, Texas, United States
NEXT OncologyRecruiting
San Antonio, Texas, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States
PASO MedicalRecruiting
Frankston, Victoria, Australia
Chongqing University Cancer HospitalRecruiting
Chongqing, Chongqing Municipality, China
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)Recruiting
Jinan, Shandong, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, China