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

March 20, 2026 updated by: Eikon Therapeutics

A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors

This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. This study includes 2 parts: Part 1 and Part 2. Part 1 includes a monotherapy dose escalation of EIK1003 followed by combination dose escalations in metastatic prostate cancer (mPC), ovarian and breast cancer.

Part 1, dose escalation, the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor.

Part 2 will explore dose optimization with selection of an optimal dose for future clinical development of EIK1003.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Phase 2
  • Phase 1

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

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Active, not recruiting
        • Scientia Clinical Research Ltd
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Cancer Care Centre, Mater Misericordiae Limited
        • Principal Investigator:
          • Catherine Shannon, MD
        • Contact:
      • Southport, Queensland, Australia, 4125
        • Not yet recruiting
        • Gold Coast Private Hospital
        • Principal Investigator:
          • Andrea Tazbirkova, MD
      • Sydney, Queensland, Australia, 2109
        • Recruiting
        • Macquarie University
        • Principal Investigator:
          • Dhanusha Sabanathan, MD
        • Contact:
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
        • Principal Investigator:
          • Wen Xu, MD
        • Contact:
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Peninsula and South Eastern Haematology and Oncology Group
        • Principal Investigator:
          • Vinod Ganju, MD
        • Contact:
          • Albert Study Coordinator
          • Phone Number: 391131349
          • Email: ag@paso.com.au
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute
        • Principal Investigator:
          • Rossanna Pezo, MD
        • Contact:
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre-University Health Network
        • Principal Investigator:
          • Amit Oza, MD
        • Contact:
  • China
      • Chongqing, China, 400044
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Li Rong, MD
        • Principal Investigator:
          • LI Yongsheng, MD
      • Hangzhou, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Chun Study Coordinator
        • Principal Investigator:
          • Zhu Jianqing, MD
      • Shanghai, China, 200120
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Principal Investigator:
          • Jian Zhang, MD
        • Contact:
        • Sub-Investigator:
          • Xiaohua Wu, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Ceng Study Coordinator
        • Principal Investigator:
          • Jundong Li, MD
  • Denmark
  • France
      • Caen, France, 14075
        • Recruiting
        • CLCC François BACLESSE
        • Principal Investigator:
          • Melanie Dos Santos, MD
        • Contact:
      • Villejuif, France, 94805
        • Recruiting
        • Institut Gustave Roussy
        • Principal Investigator:
          • Alexandra Leary, MD
        • Contact:
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • Recruiting
        • Hospices Civils de Lyon - CHU Lyon Sud
        • Principal Investigator:
          • Gilles Freyer, MD
        • Contact:
  • South Korea
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Eun Ji Study Coordinator
          • Phone Number: 82-10-6415-6275
          • Email: dmonco59@yuhs.ac
        • Principal Investigator:
          • Joo Hyuk Sohn, MD
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13496
        • Recruiting
        • CHA Bundang Medical Center, CHA University
        • Contact:
        • Principal Investigator:
          • Yong Wha Moon, MD
    • Namdong-gu
      • Incheon, Namdong-gu, South Korea, 21565
        • Recruiting
        • Gachon University - Gil Medical Center
        • Principal Investigator:
          • Young Saing Kim, MD
        • Contact:
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Principal Investigator:
          • Maria Martinez Garcia, MD
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron Institute of Oncology
        • Principal Investigator:
          • Elena Garralda, MD
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Start Madrid Fundacion Jimenez Diaz
        • Contact:
        • Principal Investigator:
          • Bernard Doger, MD
      • Madrid, Spain, 28033
        • Recruiting
        • Fundacion MD Anderson Cancer Center
        • Principal Investigator:
          • Raul Marquez, MD
        • Contact:
      • Madrid, Spain, 28050
        • Recruiting
        • START-CIOCC HM Sanchinarro Hospital
        • Contact:
        • Principal Investigator:
          • Ramón Yarza, MD
      • Seville, Spain, 41009
        • Recruiting
        • Universidad de Sevilla - Hospital Universitario Virgen Macarena
        • Principal Investigator:
          • Luis De La Cruz Merino, MD
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia - INCLIVA
        • Contact:
        • Principal Investigator:
          • Desamparados Roda, MD
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli
        • Principal Investigator:
          • Enrique Gallardo, MD
        • Contact:
    • Madrid
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Principal Investigator:
          • Jorge Bartolome, MD
        • Contact:
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clínica Universidad de Navarra - Hospital
        • Contact:
        • Principal Investigator:
          • Antonio Gonzalez, MD
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • The University of Arizona Cancer Center
        • Principal Investigator:
          • Alejandro Recio-Boiles, MD
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas Winthrop P. Rockefeller Cancer Institute
        • Principal Investigator:
          • Michael Birrer, MD
        • Contact:
          • Maroof Study Coordinator
          • Phone Number: 24576 501-686-8274
          • Email: mkzafar@uams.edu
    • California
      • Irvine, California, United States, 92618
        • Recruiting
        • Hoag Health Center Irvine
        • Principal Investigator:
          • Monica Mita, MD
        • Contact:
      • Irvine, California, United States, 92868
        • Withdrawn
        • University California Irvine
      • San Diego, California, United States, 92123
        • Withdrawn
        • Sharp Memorial Hospital
      • San Francisco, California, United States, 94158
        • Withdrawn
        • University of California San Francisco (UCSF)
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute Health One
        • Principal Investigator:
          • Gerald Falchook, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Smilow Cancer Hospital at Yale New Haven
        • Principal Investigator:
          • Patricia LoRusso, MD
        • Contact:
    • Florida
      • Celebration, Florida, United States, 34747
        • Recruiting
        • Advent Health Research Institute
        • Principal Investigator:
          • Guru Sonpavde, MD
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center
        • Principal Investigator:
          • Frances Valdes-Albini, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Rogel Cancer Center
        • Principal Investigator:
          • Aki Morikawa, MD
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
        • Principal Investigator:
          • Yusra Shao, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Principal Investigator:
          • Amy Weise, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota-Clinical Research Unit
        • Contact:
          • Elizabeth Study Coordinator
          • Phone Number: 612-626-1358
          • Email: molle086@umn.edu
        • Principal Investigator:
          • Heather Beckwith, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Withdrawn
        • Washington University - Siteman Cancer Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Withdrawn
        • John Theurer Cancer Center
    • New York
      • Ithaca, New York, United States, 14850
        • Withdrawn
        • Cayuga Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Lifespan Cancer Institute
        • Principal Investigator:
          • Benedito Carneiro, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina (MUSC) - Hollings CC
        • Principal Investigator:
          • Brian Orr, MD
        • Contact:
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • West Cancer Center & Research Institute
        • Principal Investigator:
          • Daniel Vaena, MD
        • Contact:
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institue Oncology
        • Principal Investigator:
          • Benjamin Garmezy, MD
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78229
        • Withdrawn
        • START - South Texas Accelerated Research Therapeutics
    • Utah
      • West Valley City, Utah, United States, 84119
        • Withdrawn
        • START Mountain Region

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria

  • Breast cancer; must have received at least one prior chemotherapy in neoadjuvant/adjuvant/metastatic setting, must have received hormonal therapy if HR+,
  • HGSOC or high grade endometrioid EOC, fallopian tube or primary peritoneal cancer; must have received at least one prior platinum-based chemotherapy for advanced disease
  • mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane chemotherapy
  • 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 IMP1734
  • deleterious or suspected deleterious germline or somatic mutations of select HRR genes
  • up to 1 prior line of PARP inhibitor containing treatment

Key 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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
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.
Drug: IMP1734
PARP1 selective inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with adverse events, treatment emergent adverse events or serious adverse events
Time Frame: 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
Consent to 30 + 7 days post last dose of IMP1734
Maxim Tolerated Dose or Recommended Dose for Expansion
Time Frame: 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.
DLT period is from the first dose of the study drug until the last day of the first cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters of IMP1734
Time Frame: Through study completion, up to 3 years
Peak plasma concentration (Cmax)
Through study completion, up to 3 years
Pharmacokinetic parameters of IMP1734
Time Frame: Through study completion, up to 3 years
Time to peak drug concentration (Tmax)
Through study completion, up to 3 years
Pharmacokinetic parameters of IMP1734
Time Frame: Through study completion, up to 3 years
Area under the curve (AUC) will be defined
Through study completion, up to 3 years
Overall Response Rate
Time Frame: 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
Through study completion, up to 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of the pharmacodynamic changes due to IMP1734
Time Frame: Through study completion, up to 3 years
Evaluation of serial pharmacodynamic changes across multiple doses of IMP1734
Through study completion, up to 3 years

Collaborators and Investigators

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

Sponsor

Eikon Therapeutics

Collaborators

Impact Therapeutics, Inc.

Investigators

  • Study Director: Viola Chen, MD, Eikon Therapeutics

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 Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 27, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIK1003-001 (IMP1734-101)
  • 2023-509230-19 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Solid Tumor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe