A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
- Registration Number
- NCT06253130
- Lead Sponsor
- Eikon Therapeutics
- Brief Summary
This study will evaluate the preliminary efficacy of IMP1734 in patients with recurrent advanced/metastatic breast cancer, ovarian cancer and metastatic castrate resistant prostate cancer (mCRPC) with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes.
- Detailed Description
This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. The study consists of 3 parts: Dose escalation, Dose Optimization and Dose expansion.
In dose escalation (Part1 ), the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor.
In dose optimization (Part 2), the study will further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of IMP1734.
In dose expansion (Part 3) the recommended dose escalation (RDE) of IMP1734 monotherapy will be evaluated in patients with recurrent, advanced/metastatic breast cancer, ovarian cancer and mCRPC with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) gene mutations.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
Not provided
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 IMP1734 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Overall Response Rate Through study completion, up to 3 years 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
Pharmacokinetic parameters of IMP1734 Through study completion, up to 3 years Area under the curve (AUC) will be defined
Trial Locations
- Locations (24)
Cayuga Medical Center
🇺🇸Ithaca, New York, United States
Medical University of South Carolina (MUSC) - Hollings CC
🇺🇸Charleston, South Carolina, United States
University California Irvine
🇺🇸Irvine, California, United States
University of California San Francisco (UCSF)
🇺🇸San Francisco, California, United States
Sarah Cannon Research Institute Health One
🇺🇸Denver, Colorado, United States
Smilow Cancer Hospital at Yale New Haven
🇺🇸New Haven, Connecticut, United States
Advent Health Research Institute
🇺🇸Celebration, Florida, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Washington University - Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Sarah Cannon Research Institue Oncology
🇺🇸Nashville, Tennessee, United States
Scroll for more (14 remaining)Cayuga Medical Center🇺🇸Ithaca, New York, United States