NCT06968572

Phase I Study of HSK41959 in Solid Tumors With MTAP Deletion

A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of HSK41959 in Patients With MTAP Deletion Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 245 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK41959 when given orally in patients with MTAP Deletion locally advanced or metastatic Solid Tumors.

Detailed description

The study will contain two phases: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase. Phase Ia will contain two part: Dose Escalation Part (Part A) and Extension Part (Part B). Part A based on the "3+3" design for dose escalation and safety evaluation requirements. Patient cohorts at selected doses may be extended to further investigate the tolerability, PK and PD of HSK41959. The number of patients to be enrolled will be up to 10 subjects in each Part B cohort. Approximately 30-50 subjects will be enrolled in Phase Ia. Phase Ib no less than 10-50 subjects will be enrolled in each expansion cohort.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	HSK41959	Oral administration, QD

Timeline

• Start date: 2025-04-11
• Primary completion: 2026-03-26
• Completion: 2028-05-08
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

3 sites across 1 country: China