New treatment option for Advanced Solid Tumors
Official title A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT06907043
What this study is testing
What is EIK1004-001 (IMP1707-001)?
EIK1004-001 (IMP1707-001) is an investigational medicine, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- Breast cancer: must have received at least one prior chemotherapy in neoadjuvant/adjuvant/metastatic setting, must have received hormonal therapy if...
- Age ≥ 18 years at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate organ function
- Life expectancy ≥ 12 weeks
You likely can't join if
- 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...
See the full 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...
- 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 people of childbearing potential and male people 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
- 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 \ 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...
- Known, symptomatic leptomeningeal disease.
- Have poorly controlled seizures.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Lake Mary, Florida, United States
- Boston, Massachusetts, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Frankston, Victoria, Australia
- Chongqing, Chongqing Municipality, China
- Jinan, Shandong, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Lake Mary, Florida, United States; Boston, Massachusetts, United States; Houston, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.