NCT03594422

A Study of HQP1351 in Patients With GIST or Other Solid Tumors

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral HQP1351 in Patients With GIST or Other Solid Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.

Detailed description

The primary objective of this phase 1 study is to determine the RP2D of HQP1351 in patients with GIST or other solid tumors. The secondary objective is to assess the safety, tolerability, PK and preliminary anti-tumor activities of HQP1351 in Patients With GIST or Other Solid Tumors.

Conditions

• Gastrointestinal Stromal Tumor (GIST)
• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	HQP1351	HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.

Timeline

• Start date: 2018-07-11
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2018-07-20
• Last updated: 2026-04-09

Locations

6 sites across 1 country: China