drugset / Trial / NCT03286244
Second-line CM082 Combined With Paclitaxel For Patients With Advanced Gastric Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, Phase 1b study which will be conducted in two parts: part A is the dose escalation study while part B is dose expansion study. The purpose of the dose escalation part is to identify the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CM082 combined with paclitaxel in patients with advanced gastric cancer who did not respond to first-line standard chemotherapy. In the subsequent dose expansion part, additional subjects will be enrolled to further explore the safety and preliminary clinical activity of CM082 and paclitaxel.
Timeline
- Start
- 2018-03-15
- Primary completion
- 2019-08
- Completion
- 2020-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CM082 | Unknown | 100 mg | Oral |
| Subject | CM082 | Unknown | 150 mg | Oral |
| Subject | CM082 | Unknown | 200 mg | Oral |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |