HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer

Recurrent Extensive Stage Small Cell Lung Carcinoma Clinical Trial

Official title: A Phase 1b/2, Dose-finding and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HTMC0435 With Temozolomide in Patients With Small Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

The Phase 1b part of this clinical trial is to investigate the safety and pharmacokinetic (PK) characteristics of HTMC0435 tablets combined with temozolomide in patients with various advanced solid tumors (recurrent small cell lung cancer is preferred). The Phase 2 part of the study is a multi-center, open-label, single-arm trial to investigate the preliminary efficacy of HTMC0435 and temozolomide in patients with recurrent small cell lung cancer (SCLC) at the recommended phase 2 dose.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Recurrent Extensive Stage Small Cell Lung Carcinoma
• Small Cell Lung Carcinoma

• NCT number: NCT05728619
• Study type: Interventional
• Source: Shanghai Huilun Pharmaceutical Co., Ltd.
• Contact: Jun Li
• Phone: +86-21-64311017
• Email: clinical_trial@hllife.com.cn
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 3, 2023
• Completion date: October 2024