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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06907043
Registration number
NCT06907043
Ethics application status
Date submitted
22/03/2025
Date registered
2/04/2025
Date last updated
19/08/2025
Titles & IDs
Public title
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
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Scientific title
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
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Secondary ID [1]
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IMP1707-101
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Secondary ID [2]
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EIK1004-001(IMP1707-101)
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Universal Trial Number (UTN)
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Trial acronym
EIK1004-001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Condition category
Condition code
Cancer
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - EIK1004-001 (IMP1707-001)
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.
Treatment: Drugs: EIK1004-001 (IMP1707-001)
PARP1 selective inhibitor
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants who experience a Dose-Limiting Toxicity (DLT)
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Assessment method [1]
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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.
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Timepoint [1]
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(Timeframe: up to 28 days)
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Primary outcome [2]
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Number of participants with adverse events, treatment emergent adverse events or serious adverse events
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Assessment method [2]
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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
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Timepoint [2]
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(Time Frame: 1 month post last dose of EIK1004 (IMP1707)
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Secondary outcome [1]
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Pharmacokinetic parameters of EIK1004 (IMP1707)
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Assessment method [1]
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Peak plasma concentration (Cmax)
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Timepoint [1]
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Through study completion, up to 3 years
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Secondary outcome [2]
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Pharmacokinetic parameters of EIK1004 (IMP1707)
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Assessment method [2]
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Area under the curve (AUC) will be defined
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Timepoint [2]
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Time Frame: Through study completion, up to 3 years
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Secondary outcome [3]
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Objective Response (OR)
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Assessment method [3]
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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.
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Timepoint [3]
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Through study completion, up to 3 years
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Eligibility
Key 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
* Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy.
* Previously treated CNS metastases
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Minimum age
18
Years
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Maximum age
89
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/04/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2028
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Actual
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Sample size
Target
130
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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PASO Medical - Frankston
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Recruitment postcode(s) [1]
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3199 - Frankston
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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United States of America
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State/province [5]
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Virginia
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Country [6]
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China
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State/province [6]
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Chongqing Municipality
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Country [7]
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China
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State/province [7]
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Shandong
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Country [8]
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China
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State/province [8]
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Shanghai
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eikon Therapeutics
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Impact Therapeutics, Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT06907043
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Yawei Zhang, MD
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Address
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Eikon Therapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sunny Chaudry, MS
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Address
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Country
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Phone
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6319026200
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06907043
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