Actively Recruiting
A First-in-human Study to Evaluate Safety, Tolerability, and Dose of PARP1 Inhibitor IMP1734 in Advanced Solid Tumors
Led by Eikon Therapeutics · Updated on 2026-03-23
156
Participants Needed
53
Research Sites
26 weeks
Total Duration
On this page
Sponsors
E
Eikon Therapeutics
Lead Sponsor
I
Impact Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and how the body processes and responds to IMP1734, a PARP1 selective inhibitor, in adults with advanced solid tumors. This trial focuses on patients with recurrent or metastatic cancers such as breast, ovarian, and prostate cancer. The study aims to find the best dose and understand early effects of IMP1734 when used alone, addressing treatment options for these advanced cancers. The trial includes two parts: Part 1 involves increasing doses of IMP1734 alone to find the maximum tolerated or achievable dose. This includes patients with metastatic prostate cancer, ovarian, and breast cancer. Part 2 will explore the best dose for future studies. IMP1734 is given as oral tablets daily, except during a single-dose period. Participants may be involved for up to three years after their first treatment. During the study, participants will have regular assessments for safety including monitoring adverse events and tolerability. Researchers will evaluate pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the drug's effects). They will also measure tumor response and other clinical outcomes. Follow-up will continue up to three years to monitor long-term effects and gather comprehensive data on IMP1734.
CONDITIONS
Brief Title
A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Breast cancer with prior chemotherapy in neoadjuvant, adjuvant, or metastatic setting; hormonal therapy if hormone receptor positive
- High grade serous ovarian cancer, high grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer with prior platinum-based chemotherapy
- Metastatic castration-resistant prostate cancer with ongoing androgen deprivation therapy, prior novel hormonal agent, and up to 1 prior taxane chemotherapy
- Age 18 to 89 years at informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Adequate organ function
- Life expectancy of at least 12 weeks
- Evaluable disease by RECIST 1.1 and/or CA125 or PSA
- Effective contraception use for females of childbearing potential and males from study entry until 6 months after last dose
- Presence of deleterious or suspected deleterious germline or somatic mutations in select homologous recombination repair (HRR) genes
- Up to 1 prior line of PARP inhibitor containing treatment
You will not qualify if you...
- Use of investigational or approved anti-cancer therapies within 28 days before first IMP1734 dose
- Prior treatment with PARP1 selective inhibitors
- Mean resting QTcF greater than 470 ms or less than 340 ms
- Active or untreated central nervous system metastases or carcinomatous meningitis
- Active hepatitis B or C infection
- Known bleeding disorders
- Inability to swallow oral medications or presence of malabsorption syndrome or uncontrolled gastrointestinal conditions that affect drug absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years after the last participant's first treatment
Participants receive the PARP1 selective inhibitor IMP1734 as monotherapy, taking oral tablets daily except during the single-dose period. The study includes dose escalation to identify the maximum tolerated or achievable dose, followed by dose optimization for future development.
Trial Site Locations
Total: 53 locations
1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
2
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Hoag Health Center Irvine
Irvine, California, United States, 92618
Actively Recruiting
4
University California Irvine
Irvine, California, United States, 92868
Withdrawn
5
Sharp Memorial Hospital
San Diego, California, United States, 92123
Withdrawn
6
University of California San Francisco (UCSF)
San Francisco, California, United States, 94158
Withdrawn
7
Sarah Cannon Research Institute Health One
Denver, Colorado, United States, 80218
Actively Recruiting
8
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06511
Actively Recruiting
9
Advent Health Research Institute
Celebration, Florida, United States, 34747
Actively Recruiting
10
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
11
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
12
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
13
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
14
University of Minnesota-Clinical Research Unit
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
15
Washington University - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Withdrawn
16
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Withdrawn
17
Cayuga Medical Center
Ithaca, New York, United States, 14850
Withdrawn
18
Lifespan Cancer Institute
Providence, Rhode Island, United States, 02903
Actively Recruiting
19
Medical University of South Carolina (MUSC) - Hollings CC
Charleston, South Carolina, United States, 29425
Actively Recruiting
20
West Cancer Center & Research Institute
Germantown, Tennessee, United States, 38138
Actively Recruiting
21
Sarah Cannon Research Institue Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
22
START - South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Withdrawn
23
START Mountain Region
West Valley City, Utah, United States, 84119
Withdrawn
24
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031
Active, Not Recruiting
25
Mater Cancer Care Centre, Mater Misericordiae Limited
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
26
Gold Coast Private Hospital
Southport, Queensland, Australia, 4125
Not Yet Recruiting
27
Macquarie University
Sydney, Queensland, Australia, 2109
Actively Recruiting
28
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
29
Peninsula and south eastern haematology and oncology group
Frankston, Victoria, Australia, 3199
Actively Recruiting
30
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
31
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
32
Princess Margaret Cancer Centre-University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
33
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
34
Chongqing University Cancer Hospital
Chongqing, China, 400044
Actively Recruiting
35
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Actively Recruiting
36
Fudan University Shanghai Cancer Center
Shanghai, China, 200120
Actively Recruiting
37
Righospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
38
Hospices Civils de Lyon - CHU Lyon Sud
Pierre-Bénite, Rhone, France, 69310
Actively Recruiting
39
CLCC François Baclesse
Caen, France, 14075
Actively Recruiting
40
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
41
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea, 13496
Actively Recruiting
42
Gachon University - Gil Medical Center
Incheon, Namdong-gu, South Korea, 21565
Actively Recruiting
43
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
44
Hospital Universitari Parc Taulí
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
45
Hospital Clinico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
46
Clínica Universidad de Navarra - Hospital
Pamplona, Navarre, Spain, 31008
Actively Recruiting
47
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
48
Vall d'Hebron Institute of Oncology
Barcelona, Spain, 08035
Actively Recruiting
49
Fundacion MD Anderson Cancer Center
Madrid, Spain, 28033
Actively Recruiting
50
START Madrid Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
51
START-CIOCC HM Sanchinarro Hospital
Madrid, Spain, 28050
Actively Recruiting
52
Universidad De Sevilla - Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
53
Hospital Clinico Universitario de Valencia - INCLIVA
Valencia, Spain, 46010
Actively Recruiting
Research Team
N
Nicola Lynch
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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