Advanced Solid Tumors
Conditions
Keywords
EIK1004, IMP1707, Advanced/recurrent/metastatic pancreatic adenocarcinoma, Brain metastases, Advanced HER2-negative breast adenocarcinoma, Recurrent HER2-negative breast adenocarcinoma, metastatic HER2-negative breast adenocarcinoma
Brief summary
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
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)
Interventions
DRUGEIK1004-001 (IMP1707-001)
PARP1 selective inhibitor
Sponsors
Impact Therapeutics, Inc.
Eikon Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Groups of participants are assigned to receive interventions for dose escalation in up to 7 cohorts.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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 CNS 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who experience a Dose-Limiting Toxicity (DLT) | (Timeframe: up to 28 days) | 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. |
| Number of participants with adverse events, treatment emergent adverse events or serious adverse events | (Time Frame: 1 month post last dose of EIK1004 (IMP1707) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters of EIK1004 (IMP1707) | Through study completion, up to 3 years | Peak plasma concentration (Cmax) |
| Objective Response (OR) | Through study completion, up to 3 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic changes due to EIK1004 (IMP1707) | Through study completion, up to 3 years | Cytokines will be measured using an ELISA assay. The concentration of cytokines in plasma samples collected from patients is being measured and will be reported as a quantified value (e.g ng/mL). The fold change in plasma cytokines over baseline will be measured and the relative change compared to pre-dose/baseline numbers. |
Countries
Australia, China, United States
Contacts
Primary ContactSunny Chaudry, MS
Outcome results
None listed