A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: IMP1734

• Registration Number: NCT06253130
• Lead Sponsor: Eikon Therapeutics

Brief Summary

This study will evaluate the preliminary efficacy of IMP1734 in patients with recurrent advanced/metastatic breast cancer, ovarian cancer and metastatic castrate resistant prostate cancer (mCRPC) with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes.

Detailed Description

This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. The study consists of 3 parts: Dose escalation, Dose Optimization and Dose expansion.

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 IMP1734.

In dose expansion (Part 3) the recommended dose escalation (RDE) of IMP1734 monotherapy will be evaluated in patients with recurrent, advanced/metastatic breast cancer, ovarian cancer and mCRPC with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) gene mutations.

Study Timeline

• Study Start: 2023-12-11
• Study First Submitted: 2024-01-27
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-02-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

• Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of IMP1734

• Have received prior PARP1 selective inhibitors

• Mean resting QTcF > 470 ms or QTcF < 340 ms

• Active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	IMP1734	IMP1734 monotherapy; oral tablet(s) daily (except for the single-dose period). The maximum trial duration is 3 years after the last participant's first treatment in the trial.

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events, treatment emergent adverse events or serious adverse events	Consent to 30 + 7 days post last dose of IMP1734	Number of subjects 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
Maxim Tolerated Dose or Recommended Dose for Expansion	DLT period is from the first dose of the study drug until the last day of the first cycle	Number of patients that experience a DLT or any toxicity which occurs from the time of the first dose of study drug until the end of cycle 1, which is deemed unrelated to the disease.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Through study completion, up to 3 years	Percentage of participants who have CR/PR per RECIST v1.1,and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteria
Pharmacokinetic parameters of IMP1734	Through study completion, up to 3 years	Area under the curve (AUC) will be defined

Trial Locations

Locations (24)

Cayuga Medical Center; 🇺🇸 Ithaca, New York, United States

Medical University of South Carolina (MUSC) - Hollings CC; 🇺🇸 Charleston, South Carolina, United States

University California Irvine; 🇺🇸 Irvine, California, United States

University of California San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

Sarah Cannon Research Institute Health One; 🇺🇸 Denver, Colorado, United States

Smilow Cancer Hospital at Yale New Haven; 🇺🇸 New Haven, Connecticut, United States

Advent Health Research Institute; 🇺🇸 Celebration, Florida, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Washington University - Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Sarah Cannon Research Institue Oncology; 🇺🇸 Nashville, Tennessee, United States

START - South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

START Mountain Region; 🇺🇸 West Valley City, Utah, United States

Scientia Clinical Research Ltd; 🇦🇺 Randwick, New South Wales, Australia

Mater Cancer Care Centre, Mater Misericordiae Limited; 🇦🇺 South Brisbane, Queensland, Australia

Gold Coast Private Hospital; 🇦🇺 Southport, Queensland, Australia

Macquarie University; 🇦🇺 Sydney, Queensland, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Peninsula and south eastern haematology and oncology group; 🇦🇺 Frankston, Victoria, Australia

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China

CHA Bundang Medical Center, CHA University; 🇰🇷 Seongnam-si, Gyeonggi-Do, Korea, Republic of

Gachon University - Gil Medical Center; 🇰🇷 Incheon, Namdong-gu, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of