Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b | Experimental | Escalating doses of HTMC0435 and Temozolomide |
|
| Phase 2 | Experimental | Recommended phase 2 dose (RP2D) of HTMC0435 and Temozolomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTMC0435 | Drug | Oral administration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities (DLT) of HTMC0435 combined with Temozolomide | Cycle 1 Day 1 to Cycle 1 Day 21 | |
| Adverse events (AE) of HTMC0435 combined with Temozolomide | Through study completion, an average of 6 months | |
| Maximum tolerable dose (MTD) and RP2D of HTMC0435 combined with Temozolomide | Through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic measures - the area under the concentration-time curve from dosing (time 0) to time infinity (AUC 0-inf) | Cycle 1 Day 1 to Cycle 1 Day 9 | |
| Pharmacokinetic measures - the area under the concentration-time curve from dosing (time 0) to time t (AUC 0-t) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in neuron-specific enolase (NSE) level from baseline | Through study completion, an average of 6 months | |
| Changes in pro-gastrin-releasing peptide (PROGRP) level from baseline | Through study completion, an average of 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Li | Contact | +86-21-64311017 | clinical_trial@hllife.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yun Fan, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | China | |||
| Jiangsu Province Hospital of Chinese Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Temozolomide |
| Drug |
Oral administration. |
|
| Cycle 1 Day 1 to Cycle 1 Day 9 |
| Pharmacokinetic measures - apparent clearance rate (CLz/F) | Cycle 1 Day 1 to Cycle 1 Day 9 |
| Pharmacokinetic measures - maximum plasma concentrations (Cmax) | Cycle 1 Day 1 to Cycle 1 Day 9 |
| Pharmacokinetic measures - time to reach Cmax (Tmax) | Cycle 1 Day 1 to Cycle 1 Day 9 |
| Pharmacokinetic measures - trough concentrations at steady state (Css, min) | Cycle 1 Day 1 to Cycle 1 Day 9 |
| Pharmacokinetic measures - peak concentrations at steady state (Css, max) | Cycle 1 Day 1 to Cycle 1 Day 9 |
| Pharmacokinetic measures - accumulation ratio (Rac) | Cycle 1 Day 1 to Cycle 1 Day 9 |
| Pharmacokinetic measures - terminal plasma half-life (T1/2) | Cycle 1 Day 1 to Cycle 1 Day 9 |
| Pharmacokinetic measures - apparent volume of distribution during terminal phase (Vz/F) | Cycle 1 Day 1 to Cycle 1 Day 9 |
| Objective response rate (ORR) by RECIST v1.1 | Through study completion, an average of 6 months |
| Disease control rate (DCR) by RECIST v1.1 | Through study completion, an average of 6 months |
| Progression-free survival (PFS) by RECIST v1.1 | Through study completion, an average of 6 months |
| Duration of response (DOR) by RECIST v1.1 | Through study completion, an average of 6 months |
| Overall survival (OS) by RECIST v1.1 | Through study completion, an average of 6 months |
| Recruiting |
| Nanjing |
| China |
| Henan Cancer Hospital | Recruiting | Zhengzhou | China |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |