MedTrace Logo

HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer

NCT05728619 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

  • Recurrent Extensive Stage Small Cell Lung Carcinoma

Interventions

DRUG

HTMC0435

Oral administration.

DRUG

Temozolomide

Oral administration.

Sponsors & Collaborators

  • Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yun Fan, MD · Zhejiang Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2024-08-31
Completion
2024-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05728619 on ClinicalTrials.gov