A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
Recruiting · NCT06907043 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
EIK1004-001 (IMP1707-001)
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
Who can take part
Age range
18 Years to 89 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
10 locations listed across 5 US states.
- Sarah Cannon Research Institute at HealthOne - Denver, Colorado, United States
- Florida Cancer Center - Lake Mary, Florida, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- MD Anderson - Houston, Texas, United States
- NEXT Oncology - San Antonio, Texas, United States
- NEXT Virginia - Fairfax, Virginia, United States
- Fudan University Shanghai Cancer Center - Shanghai, China
- Chongqing University Cancer Hospital - Chongqing, Chongqing Municipality, China
- Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital) - Jinan, Shandong, China
- PASO Medical - Frankston, Victoria, Australia