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NCT06253130PHASE1, PHASE2Recruiting

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

Eikon Therapeutics

Start Date

12/11/2023

Completion Date

12/1/2027

Summary

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

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.

Eligibility Criteria

Age Range: 18 years to 89 years

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

Interventions

DRUG

IMP1734

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Conditions

Advanced Solid Tumor

Locations

The University of Arizona Cancer Center

Tucson, Arizona 85719

United States

University of Arkansas Winthrop P. Rockefeller Cancer Institute

Little Rock, Arkansas 72205

United States

Hoag Health Center Irvine

Irvine, California 92618

United States

University California Irvine

Irvine, California 92868

United States

Sharp Memorial Hospital

San Diego, California 92123

United States

University of California San Francisco (UCSF)

San Francisco, California 94158

United States

Sarah Cannon Research Institute Health One

Denver, Colorado 80218

United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut 06511

United States

Advent Health Research Institute

Celebration, Florida 34747

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan 48109

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Henry Ford Health

Detroit, Michigan 48202

United States

University of Minnesota-Clinical Research Unit

Minneapolis, Minnesota 55455

United States

Washington University - Siteman Cancer Center

St Louis, Missouri 63110

United States

John Theurer Cancer Center

Hackensack, New Jersey 07601

United States

Cayuga Medical Center

Ithaca, New York 14850

United States

Lifespan Cancer Institute

Providence, Rhode Island 02903

United States

Medical University of South Carolina (MUSC) - Hollings CC

Charleston, South Carolina 29425

United States

West Cancer Center & Research Institute

Germantown, Tennessee 38138

United States

Sarah Cannon Research Institue Oncology

Nashville, Tennessee 37203

United States

START - South Texas Accelerated Research Therapeutics

San Antonio, Texas 78229

United States

START Mountain Region

West Valley City, Utah 84119

United States

Scientia Clinical Research Ltd

Randwick, New South Wales 2031

Australia

Mater Cancer Care Centre, Mater Misericordiae Limited

South Brisbane, Queensland 4101

Australia

Gold Coast Private Hospital

Southport, Queensland 4125

Australia

Macquarie University

Sydney, Queensland 2109

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Peninsula and south eastern haematology and oncology group

Frankston, Victoria 3199

Australia

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

Sunnybrook Research Institute

Toronto, Ontario M4N 3M5

Canada

Princess Margaret Cancer Centre-University Health Network

Toronto, Ontario M5G 2M9

Canada

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong 510060

China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei 050011

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang 310016

China

Chongqing University Cancer Hospital

Chongqing, 400044

China

Fujian Cancer Hospital

Fuzhou, 350000

China

Zhejiang Cancer Hospital

Hangzhou, 310022

China

Fudan University Shanghai Cancer Center

Shanghai, 200120

China

Righospitalet

Copenhagen, 2100

Denmark

Hospices Civils de Lyon - CHU Lyon Sud

Pierre-Bénite, Rhone 69310

France

CLCC François Baclesse

Caen, 14075

France

Institut Gustave Roussy

Villejuif, 94805

France

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do 13496

South Korea

Gachon University - Gil Medical Center

Incheon, Namdong-gu 21565

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Hospital Universitari Parc Taulí

Sabadell, Barcelona 08208

Spain

Hospital Clinico San Carlos

Madrid, Madrid 28040

Spain

Clínica Universidad de Navarra - Hospital

Pamplona, Navarre 31008

Spain

Hospital del Mar

Barcelona, 08003

Spain

Vall d'Hebron Institute of Oncology

Barcelona, 08035

Spain

Fundacion MD Anderson Cancer Center

Madrid, 28033

Spain

START Madrid Fundación Jiménez Díaz

Madrid, 28040

Spain

START-CIOCC HM Sanchinarro Hospital

Madrid, 28050

Spain

Universidad De Sevilla - Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Clinico Universitario de Valencia - INCLIVA

Valencia, 46010

Spain