Clinical Trials in France / NCT06253130
Recruiting
Phase 1/2
A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
NCT06253130 · tracked via the Priya Life Science France tracker
Condition(s) studied
Advanced Solid Tumor
Investigational drug(s) / intervention(s)
IMP1734
IMP1734: PARP1 selective inhibitor
Study summary
This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.
Eligibility
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
Primary outcome measure(s)
- Number of subjects with adverse events, treatment emergent adverse events or serious adverse events — Consent to 30 + 7 days post last dose of IMP1734
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 - Maxim Tolerated Dose or Recommended Dose for Expansion — DLT period is from the first dose of the study drug until the last day of the first cycle
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.
Trial sites (57)
| Facility | City | Region | Status |
|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | Recruiting |
| University of Arkansas Winthrop P. Rockefeller Cancer Institute | Little Rock | Arkansas | Recruiting |
| Hoag Health Center Irvine | Irvine | California | Withdrawn |
| University California Irvine | Irvine | California | Withdrawn |
| Sharp Memorial Hospital | San Diego | California | Withdrawn |
| University of California San Francisco (UCSF) | San Francisco | California | Withdrawn |
| Sarah Cannon Research Institute Health One | Denver | Colorado | Recruiting |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | Recruiting |
| Advent Health Research Institute | Celebration | Florida | Recruiting |
| Sylvester Comprehensive Cancer Center | Miami | Florida | Recruiting |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| Henry Ford Health | Detroit | Michigan | Recruiting |
| University of Minnesota-Clinical Research Unit | Minneapolis | Minnesota | Recruiting |
| Washington University - Siteman Cancer Center | St Louis | Missouri | Withdrawn |
| John Theurer Cancer Center | Hackensack | New Jersey | Withdrawn |
| Cayuga Medical Center | Ithaca | New York | Withdrawn |
| Lifespan Cancer Institute | Providence | Rhode Island | Recruiting |
| Medical University of South Carolina (MUSC) - Hollings CC | Charleston | South Carolina | Recruiting |
| West Cancer Center & Research Institute | Germantown | Tennessee | Recruiting |
| Sarah Cannon Research Institue Oncology | Nashville | Tennessee | Recruiting |
| START - South Texas Accelerated Research Therapeutics | San Antonio | Texas | Withdrawn |
| START Mountain Region | West Valley City | Utah | Withdrawn |
| Scientia Clinical Research Ltd | Randwick | New South Wales | Active Not Recruiting |
| Mater Cancer Care Centre, Mater Misericordiae Limited | South Brisbane | Queensland | Recruiting |
| Gold Coast Private Hospital | Southport | Queensland | Not Yet Recruiting |
| Macquarie University | Sydney | Queensland | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Recruiting |
| Peninsula and south eastern haematology and oncology group | Frankston | Victoria | Recruiting |
| Cross Cancer Institute | Edmonton | Alberta | Recruiting |
| Sunnybrook Research Institute | Toronto | Ontario | Recruiting |
| Princess Margaret Cancer Centre-University Health Network | Toronto | Ontario | Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | Recruiting |
| Shandong Cancer Hospital | Jinan | Shandong | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
| Chongqing University Cancer Hospital | Chongqing | China | Recruiting |
| Fujian Cancer Hospital | Fuzhou | China | Recruiting |
| Zhejiang Cancer Hospital | Hangzhou | China | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | China | Recruiting |
+ 17 more sites — see the full list on the official registry below.
More Eikon Therapeutics trials in France
Other trials for the same condition
Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours
Active, not recruiting
FIH XON7 in Advanced/Metastatic Solid Tumors
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06253130 on ClinicalTrials.gov ↗ ← All trials in France