drugset / Trial / NCT03286244

Second-line CM082 Combined With Paclitaxel For Patients With Advanced Gastric Cancer

NCT03286244

Phase 1 Unknown 21 enrolled AnewPharma
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

EvaluationDrugModalityDoseRoute
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

Indications