A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
Purpose
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
Condition
- Advanced Solid Tumors
Eligibility
- Eligible Ages
- Between 18 Years and 89 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy. - Previously treated CNS metastases
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
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Groups of participants are assigned to receive interventions for dose escalation in up to 7 cohorts.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1 |
EIK1004 (IMP1707) monotherapy; oral tablet(s) daily (except for the single-dose period). Participants will receive escalating doses of EIK1004 (IMP1707) until progressive disease or discontinuation. |
|
Recruiting Locations
Denver 5419384, Colorado 5417618 80218
Lake Mary 4161373, Florida 4155751 32746
Boston 4930956, Massachusetts 6254926 02215
Houston 4699066, Texas 4736286 77030
San Antonio 4726206, Texas 4736286 78229
Fairfax 4758023, Virginia 6254928 22031
More Details
- NCT ID
- NCT06907043
- Status
- Recruiting
- Sponsor
- Eikon Therapeutics
Detailed Description
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)