drugset / Trial / NCT05728619

HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer

NCT05728619

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2023-02-03
Primary completion
2024-08
Completion
2024-10

Drugs

EvaluationDrugModalityDoseRoute
Subject HTMC0435 Unknown Oral
Subject Temozolomide Small molecule Oral