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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509230-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Impact Therapeutics, Inc. | INDUSTRY |
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This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMP1734 | Drug | PARP1 selective inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of IMP1734 | Peak plasma concentration (Cmax) | Through study completion, up to 3 years |
| Pharmacokinetic parameters of IMP1734 | Time to peak drug concentration (Tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of the pharmacodynamic changes due to IMP1734 | Evaluation of serial pharmacodynamic changes across multiple doses of IMP1734 | Through study completion, up to 3 years |
Key Inclusion Criteria
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola Lynch | Contact | 212-540-4923 | 104923 | parpitrial@eikontx.com |
| Name | Affiliation | Role |
|---|---|---|
| Viola Chen, MD | Eikon Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona Cancer Center | Recruiting | Tucson | Arizona | 85719 | United States |
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| Through study completion, up to 3 years |
| Pharmacokinetic parameters of IMP1734 | Area under the curve (AUC) will be defined | Through study completion, up to 3 years |
| 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 | Through study completion, up to 3 years |
| University of Arkansas Winthrop P. Rockefeller Cancer Institute | Recruiting | Little Rock | Arkansas | 72205 | United States |
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| Hoag Health Center Irvine | Withdrawn | Irvine | California | 92618 | United States |
| University California Irvine | Withdrawn | Irvine | California | 92868 | United States |
| Sharp Memorial Hospital | Withdrawn | San Diego | California | 92123 | United States |
| University of California San Francisco (UCSF) | Withdrawn | San Francisco | California | 94158 | United States |
| Sarah Cannon Research Institute Health One | Recruiting | Denver | Colorado | 80218 | United States |
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| Smilow Cancer Hospital at Yale New Haven | Recruiting | New Haven | Connecticut | 06511 | United States |
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| Advent Health Research Institute | Recruiting | Celebration | Florida | 34747 | United States |
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| Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
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| University of Michigan Rogel Cancer Center | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
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| University of Minnesota-Clinical Research Unit | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Washington University - Siteman Cancer Center | Withdrawn | St Louis | Missouri | 63110 | United States |
| John Theurer Cancer Center | Withdrawn | Hackensack | New Jersey | 07601 | United States |
| Cayuga Medical Center | Withdrawn | Ithaca | New York | 14850 | United States |
| Lifespan Cancer Institute | Recruiting | Providence | Rhode Island | 02903 | United States |
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| Medical University of South Carolina (MUSC) - Hollings CC | Recruiting | Charleston | South Carolina | 29425 | United States |
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| West Cancer Center & Research Institute | Recruiting | Germantown | Tennessee | 38138 | United States |
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| Sarah Cannon Research Institue Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
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| START - South Texas Accelerated Research Therapeutics | Withdrawn | San Antonio | Texas | 78229 | United States |
| START Mountain Region | Withdrawn | West Valley City | Utah | 84119 | United States |
| Scientia Clinical Research Ltd | Active, not recruiting | Randwick | New South Wales | 2031 | Australia |
| Mater Cancer Care Centre, Mater Misericordiae Limited | Recruiting | South Brisbane | Queensland | 4101 | Australia |
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| Gold Coast Private Hospital | Not yet recruiting | Southport | Queensland | 4125 | Australia |
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| Macquarie University | Recruiting | Sydney | Queensland | 2109 | Australia |
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| Princess Alexandra Hospital | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
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| Peninsula and south eastern haematology and oncology group | Recruiting | Frankston | Victoria | 3199 | Australia |
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| Cross Cancer Institute | Recruiting | Edmonton | Alberta | T6G 1Z2 | Canada |
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| Sunnybrook Research Institute | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| Princess Margaret Cancer Centre-University Health Network | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310016 | China |
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| Chongqing University Cancer Hospital | Recruiting | Chongqing | 400044 | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | 350000 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | 310022 | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | 200120 | China |
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| Righospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| Hospices Civils de Lyon - CHU Lyon Sud | Recruiting | Pierre-Bénite | Rhone | 69310 | France |
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| CLCC François Baclesse | Recruiting | Caen | 14075 | France |
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| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
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| CHA Bundang Medical Center, CHA University | Recruiting | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
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| Gachon University - Gil Medical Center | Recruiting | Incheon | Namdong-gu | 21565 | South Korea |
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| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
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| Hospital Universitari Parc Taulí | Recruiting | Sabadell | Barcelona | 08208 | Spain |
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| Hospital Clinico San Carlos | Recruiting | Madrid | Madrid | 28040 | Spain |
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| Clínica Universidad de Navarra - Hospital | Recruiting | Pamplona | Navarre | 31008 | Spain |
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| Hospital del Mar | Recruiting | Barcelona | 08003 | Spain |
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| Vall d'Hebron Institute of Oncology | Recruiting | Barcelona | 08035 | Spain |
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| Fundacion MD Anderson Cancer Center | Recruiting | Madrid | 28033 | Spain |
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| START Madrid Fundación Jiménez Díaz | Recruiting | Madrid | 28040 | Spain |
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| START-CIOCC HM Sanchinarro Hospital | Recruiting | Madrid | 28050 | Spain |
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| Universidad De Sevilla - Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
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| Hospital Clinico Universitario de Valencia - INCLIVA | Recruiting | Valencia | 46010 | Spain |
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