NCT06987500

A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of XNW29016 Tablets in Advanced Solid Tumors With Failed Standard Treatment

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Evopoint Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .

Detailed description

This study is an open-label, multi-center Phase I/II clinical trial. Phase I includes the dose escalation (Stage Ia) and dose expansion (Stage Ib) phases; Phase II is an open-label, multi-center, single-arm basket study to evaluate the efficacy and safety of XNW29016 tablets in subjects with the target indications. This study consists of a screening period, a treatment period, and a follow-up period. Subjects who meet the eligibility criteria during the screening period will enter the treatment period and receive treatment with XNW29016 tablets until the study treatment is discontinued due to reasons such as disease progression or intolerable toxicity. Safety data (such as routine blood tests, routine biochemical tests, ECG, etc.) will be continuously collected during the study, and blood samples for PK (pharmacokinetics), PD (pharmacodynamics), etc. will also be collected. Efficacy evaluation will be based on different tumor types and collect different indicators. The efficacy evaluation will be conducted once every 8 weeks in the first 48 weeks from the start of the study treatment, and then once every 12 weeks.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DRUG	XNW29016	Oral Medication. The study set 7 dose level cohorts in dose escalation part.
DRUG	XNW29016	Oral Medication

Timeline

• Start date: 2025-04-11
• Primary completion: 2027-02-14
• Completion: 2027-08-16
• First posted: 2025-05-23
• Last updated: 2025-06-06

Locations

1 site across 1 country: China