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A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-11
Primary completion: 2026-02-01
Study completion finish: 2026-12-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06253130
Intervention or treatment
DRUG: IMP1734
Conditions
- • Advanced Solid Tumor
Find a site
Closest Location:
Scientia Clinical Research Ltd
Research sites nearby
Select from list below to view details:
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Mater Cancer Care Centre, Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Gold Coast Private Hospital
Southport, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Cohort 1
| DRUG: IMP1734
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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) | 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 |
Frequently Asked Questions
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