A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
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.
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion 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 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
- 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
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1PHASE2
Study ID
NCT06907043
Intervention or treatment
DRUG: EIK1004-001 (IMP1707-001)
Conditions
- Advanced Solid Tumors
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
PASO Medical
Select from list below to view details:
PASO Medical
Frankston, Victoria, Australia
Loading map...
Who is running the clinical trial?
Eikon Therapeutics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Part 1
| Drug: EIK1004-001 (IMP1707-001) |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who experience a Dose-Limiting Toxicity (DLT) | A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). The number of participants who experience a DLT will be reported. | (Timeframe: up to 28 days) |
| Number of participants with adverse events, treatment emergent adverse events or serious adverse events | Number of participants reporting adverse events or serious adverse events which include any abnormal clinical events, laboratory assessments outside of normal clinical range, abnormal vital signs observed, and any abnormal ECG parameters | (Time Frame: 1 month post last dose of EIK1004 (IMP1707) |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of EIK1004 (IMP1707) | Peak plasma concentration (Cmax) | Through study completion, up to 3 years |
| Pharmacokinetic parameters of EIK1004 (IMP1707) | Area under the curve (AUC) will be defined | Time Frame: Through study completion, up to 3 years |
| Objective Response (OR) | Defined as participants who have a complete response \[CR\] or Participants who have a partial response \[PR\] by RECIST 1.1 (Solid tumor) and RANO-BM (brain metastasis), or CA-125 response per GCIG criteria (ovarian cancer), or PSA response per PCWG3 criteria. | Through study completion, up to 3 years |
References
Clinical Trials Gov: A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.Other trials to consider
Loading suggested trials...
