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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: EIK1004-001 (IMP1707-001)

• Registration Number: NCT06907043
• Lead Sponsor: Eikon Therapeutics

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)

Study Timeline

• Study First Submitted: 2025-03-22
• Study First Submitted QC: 2025-03-31
• Study First Posted: 2025-04-02
• Study Start: 2025-04-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-18
• Primary Completion: 2028-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of EIK1004 (IMP1707)	Time Frame: Through study completion, up to 3 years	Area under the curve (AUC) will be defined
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.

Trial Locations

Locations (9)

Sarah Cannon Research Institute at HealthOne; 🇺🇸 Denver, Colorado, United States

Florida Cancer Center; 🇺🇸 Lake Mary, Florida, United States

NEXT Oncology; 🇺🇸 San Antonio, Texas, United States

NEXT Virginia; 🇺🇸 Fairfax, Virginia, United States

PASO Medical; 🇦🇺 Frankston, Victoria, Australia

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital); 🇨🇳 Jinan, Shandong, China

MD Anderson; 🇺🇸 Houston, Texas, United States

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China