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

NCT06253130 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: EIK1003-001 (IMP1734-101)2023-509230-19
• Study Type: interventional
• Target: 156
• Locations: 8 countries
• Sites: 53

Brief Summary

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

Conditions

Advanced Solid Tumor

Keywords

EIK1003; EIK1003-001; IMP1734

Outcome Measures

Primary Outcomes (2)

• Number of subjects with adverse events, treatment emergent adverse events or serious adverse events

  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

  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 Outcomes (4)

• Pharmacokinetic parameters of IMP1734

  Through study completion, up to 3 years

• Pharmacokinetic parameters of IMP1734

  Through study completion, up to 3 years

• Pharmacokinetic parameters of IMP1734

  Through study completion, up to 3 years

• Overall Response Rate

  Through study completion, up to 3 years

Other Outcomes (1)

• Characterization of the pharmacodynamic changes due to IMP1734

  Through study completion, up to 3 years

Study Arms (1)

Cohort 1

EXPERIMENTAL

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

Interventions

IMP1734 DRUG

PARP1 selective inhibitor

Cohort 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (53)

The University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

RECRUITING

University of Arkansas Winthrop P. Rockefeller Cancer Institute

Little Rock, Arkansas, 72205, United States

RECRUITING

Hoag Health Center Irvine

Irvine, California, 92618, United States

RECRUITING

University California Irvine

Irvine, California, 92868, United States

WITHDRAWN

Sharp Memorial Hospital

San Diego, California, 92123, United States

WITHDRAWN

University of California San Francisco (UCSF)

San Francisco, California, 94158, United States

WITHDRAWN

Sarah Cannon Research Institute Health One

Denver, Colorado, 80218, United States

RECRUITING

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06511, United States

RECRUITING

Advent Health Research Institute

Celebration, Florida, 34747, United States

RECRUITING

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

University of Minnesota-Clinical Research Unit

Minneapolis, Minnesota, 55455, United States

RECRUITING

Washington University - Siteman Cancer Center

St Louis, Missouri, 63110, United States

WITHDRAWN

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

WITHDRAWN

Cayuga Medical Center

Ithaca, New York, 14850, United States

WITHDRAWN

Lifespan Cancer Institute

Providence, Rhode Island, 02903, United States

RECRUITING

Medical University of South Carolina (MUSC) - Hollings CC

Charleston, South Carolina, 29425, United States

RECRUITING

West Cancer Center & Research Institute

Germantown, Tennessee, 38138, United States

RECRUITING

Sarah Cannon Research Institue Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

START - South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

WITHDRAWN

START Mountain Region

West Valley City, Utah, 84119, United States

WITHDRAWN

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

ACTIVE NOT RECRUITING

Mater Cancer Care Centre, Mater Misericordiae Limited

South Brisbane, Queensland, 4101, Australia

RECRUITING

Gold Coast Private Hospital

Southport, Queensland, 4125, Australia

NOT YET RECRUITING

Macquarie University

Sydney, Queensland, 2109, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Peninsula and south eastern haematology and oncology group

Frankston, Victoria, 3199, Australia

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre-University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, 400044, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, 310022, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, 200120, China

RECRUITING

Righospitalet

Copenhagen, 2100, Denmark

RECRUITING

Hospices Civils de Lyon - CHU Lyon Sud

Pierre-Bénite, Rhone, 69310, France

RECRUITING

CLCC François Baclesse

Caen, 14075, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 13496, South Korea

RECRUITING

Gachon University - Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Clínica Universidad de Navarra - Hospital

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Vall d'Hebron Institute of Oncology

Barcelona, 08035, Spain

RECRUITING

Fundacion MD Anderson Cancer Center

Madrid, 28033, Spain

RECRUITING

START Madrid Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

START-CIOCC HM Sanchinarro Hospital

Madrid, 28050, Spain

RECRUITING

Universidad De Sevilla - Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Clinico Universitario de Valencia - INCLIVA

Valencia, 46010, Spain

RECRUITING

Study Officials

• Viola Chen, MD

  Eikon Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Nicola Lynch

CONTACT

212-540-4923; parpitrial@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

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 12, 2024
• Study Start: December 11, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

AU (6); ES (10); KR (3); FR (3); CA (3); US (23); CN (4); DK (1)