Trials / Unknown
UnknownNCT05728619
HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer
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
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- Sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HTMC0435 | Oral administration. |
| DRUG | Temozolomide | Oral administration. |
Timeline
- Start date
- 2023-02-03
- Primary completion
- 2024-08-01
- Completion
- 2024-10-01
- First posted
- 2023-02-15
- Last updated
- 2023-09-28
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05728619. Inclusion in this directory is not an endorsement.