A Study Of PARP1 Selective Inhibitor, EIK1004 (IMP1707) In Participants With Advanced Solid Tumors.

Study Overview

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

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)

Advanced Solid Tumors

DRUG: EIK1004-001 (IMP1707-001)

EIK1004-001(IMP1707-101)
IMP1707-101 (OTHER Identifier) (OTHER: IMPACT Therapeutics Inc.)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-03-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-18
First Submitted that Met QC Criteria 2025-03-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-19
First Posted (ACTUAL) 2025-04-02	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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.	DRUG: EIK1004-001 (IMP1707-001) PARP1 selective inhibitor

Participant Group/Arm

Intervention/Treatment

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.

DRUG: EIK1004-001 (IMP1707-001)

PARP1 selective inhibitor

Primary Outcome Measures	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 Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sunny Chaudry, MS

Phone Number: 6319026200

Email: chaudrys@eikontx.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Impact Therapeutics, Inc.

Investigators

STUDY_DIRECTOR: Yawei Zhang, MD, Eikon Therapeutics

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record