NCT05260385

To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors

A Phase Ib / II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Digestive System Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 133 (estimated)
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the preliminary efficacy, safety, tolerability and pharmacokinetics of KC1036 in participants with advanced recurrent or metastatic digestive system tumors.

Detailed description

This is an open label, non-randomized，phase 1b/2 study to explore the preliminary antitumor activity of KC1036 in patients with advanced recurrent or metastatic digestive system tumors under BID or QD regimen. The study will consist of two parts: Part 1: QD regimen To evaluate the efficacy and safety of KC1036 in the treatment of advanced recurrent, unresectable and / or metastatic digestive system tumors under 60mg QD regimen. Part 2: BID regimen Dose-Escalation part : To explore the safety of KC1036 under 20mg BID, 30mg BID and 40mg BID in patients with advanced recurrent or metastatic digestive system tumors. Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion to evaluate the effectiveness and safety of KC1036 in patients with advanced recurrent, unresectable and / or metastatic digestive system tumors.

Conditions

• Digestive System Tumors

Interventions

Type	Name	Description
DRUG	KC1036	KC1036 are administered orally QD or BID in 21-day cycles.

Timeline

• Start date: 2022-01-24
• Primary completion: 2025-10-30
• Completion: 2025-12-30
• First posted: 2022-03-02
• Last updated: 2024-10-17

Locations

13 sites across 1 country: China