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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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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

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

EIK1004-001 (IMP1707-001)

Intervention Type DRUG

PARP1 selective inhibitor

Interventions

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EIK1004-001 (IMP1707-001)

PARP1 selective inhibitor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No