NCT05451602

HEC169096 in Participants With Advanced Solid Tumors

Phase 1/2 Study of the Highly-selective RET Inhibitor,HEC169096 in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors.

Detailed description

This is an open-label, multi-center Phase 1/2 study in participants with advanced solid tumors, including RET fusion-positive NSCLC, MTC, and other tumors with RET activation. Phase I of this study includes a dose-escalation phase and a dose-expansion phase , which will focus on exploring MTD and/or RP2D of HEC169096 in patients with advanced solid tumours; Phase II will assess the efficacy and safety of HEC169096 at the RP2D dose.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HEC169096	Multiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2.

Timeline

• Start date: 2022-10-21
• Primary completion: 2025-07-30
• Completion: 2027-08-30
• First posted: 2022-07-11
• Last updated: 2022-10-27

Locations

1 site across 1 country: China