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Brief Title: HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer
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
Study ID: NCT05728619
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Zhejiang Cancer Hospital, Hangzhou, , China
Jiangsu Province Hospital of Chinese Medicine, Nanjing, , China
Henan Cancer Hospital, Zhengzhou, , China
Name: Yun Fan, MD
Affiliation: Zhejiang Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR