The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .
Patients must have the ability to understand and sign an approved informed consent form (ICF).
Age at the time of consent ≥ 18 years;
Life expectancy of ≥ 3 months;
For prostate adenocarcinoma, at least one evaluable lesion by RECIST v1.1 and PCWG3 criteria; for other advanced solid tumor, at least one measurable lesion by RECIST v1.1 criteria.
Any previous treatment with a PARG inhibitor.
Subjects known to be allergic to the study drug or its active ingredients or excipients;
Subjects who received anti-tumor therapies including chemotherapy, immunotherapy, radical radiotherapy, major surgery, targeting therapy and other anti-tumor therapies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose; or received palliative radiotherapy within 2 weeks before the first dose;
Subjects who participated in any other clinical trial of anti-tumor therapy within 28 days before the first dosing, and the last dose of other anti-tumor trial drug is within 28 days prior to the first administration of study drug in this trial;
Single group
XNW29016
DrugOral Medication. The study set 7 dose level cohorts in dose escalation part.
XNW29016
DrugOral Medication
Ph Ia/Ib: Overall safety profile including adverse events
* Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[5.0\]) * Incidence of Dose Limiting Toxicities
Ph Ia/Ib: Recommended phase 2 doses (RP2D) of XNW29016
RP2D of XNW29016 as administered orally twice daily (BID), continuously in 28-day cycles, in subjects by safety data, pharmacokinetic data, pharmacodynamic data and efficacy data
Ph Ia/Ib: Pharmacokinetic Parameters
The area under the plasma concentration-time curve (AUC)
Ph Ia/Ib: Pharmacokinetic Parameters
Maximum plasma concentration (Cmax)
Ph Ia/Ib: Pharmacokinetic Parameters
Elimination half-life (t1/2)
Ph Ia/Ib: Pharmacodynamic Parameters
The relative change of PAR with the baseline before and after administration
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Evopoint Biosciences Inc.
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
