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

NCT06907043 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: EIK1004-001(IMP1707-101)IMP1707-101
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 10

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

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pharmacokinetic parameters of EIK1004 (IMP1707)

  Through study completion, up to 3 years

• Pharmacokinetic parameters of EIK1004 (IMP1707)

  Time Frame: Through study completion, up to 3 years

• Objective Response (OR)

  Through study completion, up to 3 years

Other Outcomes (1)

• Pharmacodynamic changes due to EIK1004 (IMP1707)

  Through study completion, up to 3 years

Study Arms (1)

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.

Drug: EIK1004-001 (IMP1707-001)

Interventions

EIK1004-001 (IMP1707-001) DRUG

PARP1 selective inhibitor

Part 1

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy.
• Previously treated CNS metastases

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Eikon Therapeutics: lead
• Impact Therapeutics, Inc.: collaborator

Study Sites (10)

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, 80218, United States

RECRUITING

Florida Cancer Center

Lake Mary, Florida, 32746, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

PASO Medical

Frankston, Victoria, 3199, Australia

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)

Jinan, Shandong, 250117, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yawei Zhang, MD

  Eikon Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Sunny Chaudry, MS

CONTACT

6319026200; chaudrys@eikontx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Groups of participants are assigned to receive interventions for dose escalation in up to 7 cohorts.

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 2, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

AU (1); CN (3); US (6)