Actively Recruiting
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
Led by Eikon Therapeutics · Updated on 2025-08-19
130
Participants Needed
10
Research Sites
187 weeks
Total Duration
On this page
Sponsors
E
Eikon Therapeutics
Lead Sponsor
I
Impact Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 89 years at the time of informed consent
- Diagnosed with recurrent advanced/metastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer, or pancreatic cancer
- Breast cancer patients must have received at least one prior chemotherapy and hormonal therapy if HR+, high grade serous ovarian cancer or high grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer; and at least one prior platinum-based chemotherapy for advanced disease
- mCRPC patients must have ongoing androgen deprivation therapy, received novel hormonal agents and up to one prior line of taxane chemotherapy
- Pancreatic cancer patients must have had prior first-line therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Adequate organ function
- Life expectancy of at least 12 weeks
- Must have evaluable disease per RECIST1.1 and/or CA125 or PSA markers
- Female subjects of childbearing potential and male subjects must agree to use effective contraception from study entry up to six months after last dose
- Must have deleterious or suspected deleterious germline or somatic mutations in selected homologous recombination repair (HRR) genes
- Up to one prior line of PARP inhibitor containing treatment allowed
- Participants with untreated or previously treated CNS metastases not requiring immediate local therapy are eligible
You will not qualify if you...
- Use of any investigational or approved anti-cancer therapies within 28 days before first dose of EIK1004
- Prior treatment with PARP1 selective inhibitors
- Mean resting QTcF greater than 470 ms or less than 340 ms
- Active hepatitis B or C infection
- Known predisposition to bleeding
- Unable to swallow oral medications or have malabsorption syndrome or uncontrolled gastrointestinal conditions that may affect drug absorption
- Untreated brain lesions larger than 2.0 cm
- Ongoing systemic corticosteroid use for CNS metastases symptoms within 7 days prior to first dose, or requirement for more than 10 mg prednisone per day
- Brain lesions needing immediate local therapy, including lesions in sensitive anatomical sites such as brain stem
- Known symptomatic leptomeningeal disease
- Poorly controlled seizures
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States, 80218
Actively Recruiting
2
Florida Cancer Center
Lake Mary, Florida, United States, 32746
Actively Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
5
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
6
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
7
PASO Medical
Frankston, Victoria, Australia, 3199
Actively Recruiting
8
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
9
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, China, 250117
Actively Recruiting
10
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
S
Sunny Chaudry, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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