NCT05683886

A Study of KC1036 in Patients with Advanced Thymic Tumors

A Single-arm, Open, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Thymic Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm，open-label, multicentric, phase II study to evaluate the efficacy and safety of KC1036 in patients with advanced recurrent or metastatic thymoma or thymic carcinoma.

Detailed description

Thymus tumor is a relatively rare type of thoracic tumor. Patients with thymus tumor who have failed to receive first-line chemotherapy lack of effective therapeutic drugs and clinical need is urgent. Previous phase I study showed that KC1036 has a good therapeutic effect in patients with advanced thymic tumors, and KC1036 is safe and well tolerated in patients with advanced tumors. This study further explored the efficacy and safety of KC1036 in patients with advanced thymic tumors. Patients will receive continuous treatment with oral KC1036 60 mg once daily. Each cycle will be considered as 21 days of treatment; safety was assessed every 21 days. Tumor assessement will be done every two cycles. Treatment should be administered until documented disease progression, unacceptable toxicity, or patient refusal.

Conditions

• Thymic Tumors

Interventions

Type	Name	Description
DRUG	KC1036	Patients take 60mg QD of KC1036 for the efficacy and safety study. KC1036 are given orally once daily, 21 days as a cycle.

Timeline

• Start date: 2023-02-22
• Primary completion: 2025-02-01
• Completion: 2026-02-01
• First posted: 2023-01-13
• Last updated: 2024-10-17

Locations

2 sites across 1 country: China