This is a Phase 1, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HSK46256 tablets, a selective PARP1 inhibitor, in patients with advanced solid tumors. The study consists of a dose escalation phase and a dose expansion phase. In the dose escalation phase, a 3+3 dose escalation design will be used to evaluate multiple dose levels. The dose expansion phase will enroll patients into expansion cohorts at selected dose levels to further evaluate safety and preliminary efficacy.
Age ≥18 years, voluntarily participate and provide signed informed consent,
ECOG performance status 0-1 or KPS >60; estimated life expectancy ≥12 weeks,
Histologically or cytologically confirmed locally advanced or metastatic solid tumors, failed prior standard therapy, intolerant to standard therapy, or no available standard therapy,
Dose escalation: prior treatment with one line of non-selective PARP inhibitor allowed,
Other malignancies within past 2 years (except adequately treated basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma);
Uncontrolled moderate to large pleural, pericardial, or peritoneal effusions;
Prior anticancer therapy or concomitant use of CYP3A4 strong/moderate inhibitors/inducers within protocol-specified washout periods;
Prior anticancer treatment toxicity not resolved to CTCAE ≤Grade 1 (except alopecia, skin toxicity);
Single group
HSK46256
DrugOral administration. Dose escalation: an initial single-dose period followed by multiple-dose cycles until disease progression or intolerable toxicity. Dose expansion: multiple-dose cycles directly. Specific dose levels and dosing frequency will be determined based on dose-escalation data.
DLTs
Incidence of dose-limiting toxicities (DLTs) at Cycle1
MTD
Maximum Tolerated Dose
Progression-Free Survival (PFS)
Duration of Response (DOR)
Disease Control Rate (DCR)
Radiographic Progression-Free Survival (rPFS, prostate cancer only)
Pharmacodynamic (PD) markers: PARP1 inhibition and biomarker modulation
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
