Advanced Solid TumorsPhase 1/2EIK1004-001NCT06907043
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
A Phase 1/2 study testing EIK1004-001 (IMP1707-001) in people with Advanced Solid Tumors, run by Eikon Therapeutics at 10 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- EIK1004-001 (IMP1707-001)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 30 Apr 2025to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
United States6 sites, 6 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Gary Barahona, 617-975-7474, gbaraho1@bidmc.harvard.edu
- Recruiting
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218
Shelby Mosier-Murray, 720-701-0123, Shelby.MosierMurray@sarahcannon.com
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Nicole Bryson, 703-783-4510, nbryson@nextoncology.com
- Recruiting
MD Anderson
Houston, Texas, 77030
Cindy Bang, 877-632-6789, cbang@mdanderson.org
- Recruiting
Florida Cancer Center
Lake Mary, Florida, 32746
Alexander Philipovskiy, 407-804-6133, alexander.philipovskiy@flcancer.com
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
China Whitwer, 210-580-9500, cwhitwer@nextoncology.com
China3 sites, 3 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Yongsheng Li-PI, 023-65311341, yongshengli2005@163.com
- Recruiting
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, 250117
Yuping Sun, 0531-67626073, 13370582181@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Yunyan Guo, guoyunyan@solemed.com.cn
Australia1 site, 1 recruiting
- Recruiting
PASO Medical
Frankston, Victoria, 3199
Vinod Ganju, 397815244, vg@paso.com.au
About this study
Official 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
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
Read the 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)
- Conditions
- Advanced Solid Tumors
- Being tested
- EIK1004-001 (IMP1707-001)
- 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
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIK1004-001 (IMP1707-001)Drug
PARP1 selective inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | 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. Receives: Drug: EIK1004-001 (IMP1707-001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (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
Measured: (Time Frame: 1 month post last dose of EIK1004 (IMP1707)
Secondary outcomes (3)
Pharmacokinetic parameters of EIK1004 (IMP1707)
Peak plasma concentration (Cmax)
Measured: Through study completion, up to 3 years
Pharmacokinetic parameters of EIK1004 (IMP1707)
Area under the curve (AUC) will be defined
Measured: 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.
Measured: Through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start30 Apr 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Groups of participants are assigned to receive interventions for dose escalation in up to 7 cohorts.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eikon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Impact Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Yawei Zhang, MD, Study director, Eikon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907043
- Sponsor's protocol ID
- EIK1004-001(IMP1707-101)
- Other IDs
- IMP1707-101
- Acronym
- EIK1004-001
- Status last verified
- Aug 2025
- First submitted
- 22 Mar 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06907043
- Acronym / sponsor ID
- EIK1004-001 / EIK1004-001(IMP1707-101)
- Conditions
- Advanced Solid Tumors
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Eikon TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Impact Therapeutics, Inc.
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Groups of participants are assigned to receive interventions for dose escalation in up to 7 cohorts.
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: EIK1004-001 (IMP1707-001)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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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
- Any known predisposition to bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIK1004-001 (IMP1707-001)PARP1 selective inhibitor | Drug | Part 1 |
Primary outcome
Number of Participants who experience a Dose-Limiting Toxicity (DLT)
Time frame: (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: (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
3 secondary outcomes
Pharmacokinetic parameters of EIK1004 (IMP1707)
Time frame: Through study completion, up to 3 years
Pharmacokinetic parameters of EIK1004 (IMP1707)
Time frame: Time Frame: Through study completion, up to 3 years
Objective Response (OR)
Time frame: Through study completion, up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yawei Zhang, MD study director
Eikon Therapeutics
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EIK1004-001 (IMP1707-001) in people with Advanced Solid Tumors, run by Eikon Therapeutics at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunny Chaudry, MS (6319026200, chaudrys@eikontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who experience a Dose-Limiting Toxicity (DLT) (time frame: (Timeframe: up to 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.