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Advanced Solid TumorPhase 1/2NCT06253130

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

A Phase 1/2 study testing IMP1734 in people with Advanced Solid Tumor, run by Eikon Therapeutics at 57 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
IMP1734
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
57 sitesin 8 countries
Study dates
11 Dec 2023to 1 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

57 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Nicola Lynch contact

212-540-4923 ext. 104923

parpitrial@eikontx.com

57 sites in 8 countries

United States23 sites, 14 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Myron Study Coordinator, 734-998-4415, mhepner@med.umich.edu

    Aki Morikawa, MD

    Recruiting

  • Advent Health Research Institute

    Celebration, Florida, 34747

    Jamayra Study Coordinator, jamayra.espada@adventhealth.com

    Guru Sonpavde, MD

    Recruiting

  • Medical University of South Carolina (MUSC) - Hollings CC

    Charleston, South Carolina, 29425

    Abigail Study Coordinator, abd300@musc.edu

    Brian Orr, MD

    Recruiting

  • Sarah Cannon Research Institute Health One

    Denver, Colorado, 80218

    Hannah Study Nurse, 720-754-2610, Hannah.Asbell@SarahCannon.com

    Gerald Falchook, MD

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Brenda Research Nurse, 313-576-8408, kramerb@karmanos.org

    Yusra Shao, MD

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Andrew Study Coordinator, 313-439-0182, aanasto1@HFHS.ORG

    Amy Weise, MD

    Recruiting

  • West Cancer Center & Research Institute

    Germantown, Tennessee, 38138

    Rebecca Study Coordinator, rblair@westclinic.com

    Daniel Vaena, MD

    Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

    Withdrawn

  • Hoag Health Center Irvine

    Irvine, California, 92618

    Withdrawn

  • University California Irvine

    Irvine, California, 92868

    Withdrawn

  • Cayuga Medical Center

    Ithaca, New York, 14850

    Withdrawn

  • University of Arkansas Winthrop P. Rockefeller Cancer Institute

    Little Rock, Arkansas, 72205

    Maroof Study Coordinator, 501-686-8274 ext. 24576, mkzafar@uams.edu

    Michael Birrer, MD

    Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Lauren Study Coordinator, 305-243-8237, laurenwalsh@med.miami.edu

    Frances Valdes-Albini, MD

    Recruiting

  • University of Minnesota-Clinical Research Unit

    Minneapolis, Minnesota, 55455

    Elizabeth Study Coordinator, 612-626-1358, molle086@umn.edu

    Heather Beckwith, MD

    Recruiting

  • Sarah Cannon Research Institue Oncology

    Nashville, Tennessee, 37203

    Emma Study Coordinator, (615) 917 - 9153, Emma.Brennan@scri.com

    Benjamin Garmezy, MD

    Recruiting

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06511

    Sarah Reinwald, 203-314-7175, sarah.reinwald@yale.edu

    Patricia LoRusso, MD

    Recruiting

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903

    Sopha Research Nurse, 401.444.8946, sdionson@brownhealth.org

    Benedito Carneiro, MD

    Recruiting

  • START - South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

    Withdrawn

  • Sharp Memorial Hospital

    San Diego, California, 92123

    Withdrawn

  • University of California San Francisco (UCSF)

    San Francisco, California, 94158

    Withdrawn

  • Washington University - Siteman Cancer Center

    St Louis, Missouri, 63110

    Withdrawn

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

    Spencer Study Coordinator, 520-694-4374, spencerwilliams@arizona.edu

    Alejandro Recio-Boiles, MD

    Recruiting

  • START Mountain Region

    West Valley City, Utah, 84119

    Withdrawn

Other trials in United States

Spain10 sites, 10 recruiting

  • Hospital del Mar

    Barcelona, 08003

    Laia Study Coordinator, 678165121, lcano@psmar.cat

    Maria Martinez Garcia, MD

    Recruiting

  • Vall d'Hebron Institute of Oncology

    Barcelona, 08035

    Eulalia Study Coordinator, 93 274 60 00 ext. 3604, ealiende@vhio.net

    Elena Garralda, MD

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040

    Raquel Study Coordinator, 34 91 330 30 00, raquelrodam@gmail.com

    Jorge Bartolome, MD

    Recruiting

  • Fundacion MD Anderson Cancer Center

    Madrid, 28033

    Mirian Study Coordinator, +34917878600 ext. 2883, mirian.delgado@fundacionmdanderson.es

    Raul Marquez, MD

    Recruiting

  • START Madrid Fundación Jiménez Díaz

    Madrid, 28040

    Leticia Study Coordinator, +34915504800 ext. 3710, leticia.bollo@startmadrid.com

    Bernard Doger, MD

    Recruiting

  • START-CIOCC HM Sanchinarro Hospital

    Madrid, 28050

    Isabel Study Coordinator, +34 91 756 78 00, isabel.serna@startmadrid.com

    Ramón Yarza, MD

    Recruiting

  • Clínica Universidad de Navarra - Hospital

    Pamplona, Navarre, 31008

    Estibaliz Study Coordinator, 948296666 ext. 2712, esgonzalez@unav.es

    Antonio Gonzalez, MD

    Recruiting

  • Hospital Universitari Parc Taulí

    Sabadell, Barcelona, 08208

    Jose Garcia Study Coordinator, 0034 937240084, jgarciar@tauli.cat

    Enrique Gallardo, MD

    Recruiting

  • Universidad De Sevilla - Hospital Universitario Virgen Macarena

    Seville, 41009

    Maria Study Coordinator, +34629310196, mariacandon.oncomacarena@gmail.com

    Luis De La Cruz Merino, MD

    Recruiting

  • Hospital Clinico Universitario de Valencia - INCLIVA

    Valencia, 46010

    Andres Study Coordinator, 34961973543, andres.cervantes@uv.es

    Desamparados Roda, MD

    Recruiting

Other trials in Spain

China8 sites, 8 recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400044

    Dingkun Study Coordinator, wang_dingkun@wuxiapptec.com

    Li Rong, MD

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, 350000

    wufan_fj@163.com

    Wu Fan, MD

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ceng Study Coordinator

    Jundong Li, MD

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    wangxian@srrsh.com

    Xian Wang, MD

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Chun Study Coordinator

    Zhu Jianqing, MD

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    15553103209@163.com

    Huihui Li, MD

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

    Xiang Study Coordinator, 17703993082, xiang.li@solemed.com.cn

    Jian Zhang, MD

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    cuizhi_geng@163.com

    Cuizhi Geng, MD

    Recruiting

Other trials in China

Australia6 sites, 5 recruiting

  • Peninsula and south eastern haematology and oncology group

    Frankston, Victoria, 3199

    Albert Study Coordinator, 391131349, ag@paso.com.au

    Vinod Ganju, MD

    Recruiting

  • Scientia Clinical Research Ltd

    Randwick, New South Wales, 2031

    Active, not recruiting

  • Mater Cancer Care Centre, Mater Misericordiae Limited

    South Brisbane, Queensland, 4101

    Michael Study Coordinator, 07 3163 8331, michael.chambers@mater.org.au

    Catherine Shannon, MD

    Recruiting

  • Gold Coast Private Hospital

    Southport, Queensland, 4125

    Andrea Tazbirkova, MD

    Not yet recruiting

  • Macquarie University

    Sydney, Queensland, 2109

    Rebecca Study Coordinator, 006129812 2975, rebecca.bisseh@mq.edu.au

    Dhanusha Sabanathan, MD

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Ambber Study Coordinator, ambber.ward@health.qld.gov.au

    Wen Xu, MD

    Recruiting

Other trials in Australia

Canada3 sites, 3 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Noor Study Coordinator, noor.khattak@albertahealthservices.ca

    Quincy Chu, MD

    Recruiting

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

    Donna Study Coordinator, donna.morgan1@sunnybrook.ca

    Rossanna Pezo, MD

    Recruiting

  • Princess Margaret Cancer Centre-University Health Network

    Toronto, Ontario, M5G 2M9

    Riya Study Coordinator, riya.agrawal@uhn.ca

    Amit Oza, MD

    Recruiting

Other trials in Canada

France3 sites, 3 recruiting

  • CLCC François Baclesse

    Caen, 14075

    Sophie Study Coordinator, 0231455050 ext. 53.76, s.danet@baclesse.unicancer.fr

    Melanie Dos Santos, MD

    Recruiting

  • Hospices Civils de Lyon - CHU Lyon Sud

    Pierre-Bénite, Rhone, 69310

    Guillemine Study Coordinator, 00 33 4 78 86 12 21, guillemine.dherret@chu-lyon.fr

    Gilles Freyer, MD

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Mariem Study Coordinator, +33 1 42 11 61 72, mariem.labiadh@gustaveroussy.fr

    Alexandra LEARY, MD

    Recruiting

Other trials in France

South Korea3 sites, 3 recruiting

  • Gachon University - Gil Medical Center

    Incheon, Namdong-gu, 21565

    Hyerim Study Coordinator, 82-10-9930-7579, jasmin993075@naver.com

    Young Saing Kim, MD

    Recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13496

    Haelim Study Coordinator, 82-31-780-5304, cholong872@gmail.com

    Yong Wha Moon, MD

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Eun Ji Study Coordinator, 82-10-6415-6275, dmonco59@yuhs.ac

    Joo Hyuk Sohn, MD

    Recruiting

Other trials in South Korea

Denmark1 site, 1 recruiting

  • Righospitalet

    Copenhagen, 2100

    Solvej Study Coordinator, solvej.thao.thanh.le.truong@regionh.dk

    Martin Hoejgaard, MD

    Recruiting

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
IMP1734
Keywords
EIK1003, EIK1003-001, IMP1734

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMP1734Drug

    PARP1 selective inhibitor

Study groups in NCT06253130
Study groupRoleWhat they receive
Cohort 1ExperimentalIMP1734 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.
Receives: Drug: IMP1734

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Consent to 30 + 7 days post last dose of IMP1734

  2. 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.

    Measured: DLT period is from the first dose of the study drug until the last day of the first cycle

Secondary outcomes (4)

  1. Pharmacokinetic parameters of IMP1734

    Peak plasma concentration (Cmax)

    Measured: Through study completion, up to 3 years

  2. Pharmacokinetic parameters of IMP1734

    Time to peak drug concentration (Tmax)

    Measured: Through study completion, up to 3 years

  3. Pharmacokinetic parameters of IMP1734

    Area under the curve (AUC) will be defined

    Measured: Through study completion, up to 3 years

  4. Overall Response Rate

    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

    Measured: Through study completion, up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start11 Dec 2023
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06253130
Sponsor's protocol ID
EIK1003-001 (IMP1734-101)
Other IDs
2023-509230-19, 2023
Status last verified
Jun 2026
First submitted
27 Jan 2024
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMP1734 in people with Advanced Solid Tumor, run by Eikon Therapeutics at 57 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Spain, China, Australia, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicola Lynch (212-540-4923 ext. 104923, parpitrial@eikontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06253130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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