NCT07134998

Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations

A Phase I Study of HRS-6093 Evaluating Safety, Tolerability, and Pharmacokinetics in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors. The study consists of dose escalation, dose expansion and efficacy expansion.

Conditions

• Advanced KRAS G12D Mutant Solid Tumors

Interventions

Type	Name	Description
DRUG	HRS-6093	HRS-6093

Timeline

• Start date: 2025-09-16
• Primary completion: 2028-05-01
• Completion: 2028-12-01
• First posted: 2025-08-21
• Last updated: 2025-12-05

Locations

2 sites across 1 country: China