NCT06907043RecruitingPhase 1/2
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 22 Mar 2025
- Start date
- 30 Apr 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Eikon Therapeutics
- Diseases
- Pancreatic cancer
- NCT number
- NCT06907043
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 130
- From 30 Apr 2025 to the primary completion date, Dec 2028
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received prior PARP1 selective inhibitors
- 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).
Other illness
- Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of EIK1004 (IMP1707)
- 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
- Known, symptomatic leptomeningeal disease.
- Have poorly controlled seizures.
Other
- Mean resting QTcF \> 470 ms or QTcF \< 340 ms
- Any untreated brain lesions \> 2.0 cm in size.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PASO Medical Coordinator of this site? Confirm its status | Frankston | Australia | Recruiting |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital) Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Sarah Cannon Research Institute at HealthONE Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| MD Anderson Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Florida Cancer Center Coordinator of this site? Confirm its status | Lake Mary | United States | Recruiting |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.