NCT06536400

Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation

A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of HSK42360 in Patients With BRAF V600 Mutation Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 316 (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 HSK42360 when given orally in patients with active BRAF V600 mutation 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 HSK42360. The number of patients to be enrolled will be up to 10 subjects in each Part B cohort. Approximately 30-70 subjects will be enrolled in Phase Ia. Phase Ib no less than 10-50 subjects will be enrolled in each expansion cohort.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	HSK42360	Oral administration, QD

Timeline

• Start date: 2024-06-25
• Primary completion: 2026-08-30
• Completion: 2027-07-07
• First posted: 2024-08-05
• Last updated: 2024-08-05

Locations

13 sites across 1 country: China