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HX008 with or without Irinotecan in Advanced Solid Tumors
NCT03704246Phase 2
Key facts
- Status
- Unknown
- Start
- Sep 2018
- Primary completion
- Dec 2019
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- pucotenlimab
- Conditions
- gastric adenocarcinomasolid tumor
01
Overview
Phase 2, open-label trial of pucotenlimab in gastric adenocarcinoma and solid tumor (2 arms), sponsored by Taizhou Hanzhong Pharmaceuticals. Primary endpoint: Overall Response Rate at 2 years. Status: unknown.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Gastric Cancer Combo
HX008 + Irinotecan for advanced gastric adenocarcinoma.
MSI-H/dMMR Monotherapy
HX008 monotherapy for advanced MSI-H/dMMR solid tumors.
03
Who it enrols
Adult patients with advanced gastric adenocarcinoma who failed first-line chemotherapy (Cohort 1) or patients with advanced MSI-H/dMMR solid tumors who failed at least one line of standard therapy (Cohort 2).
04
Endpoints
Primary
Overall Response Rate
Secondary
Safety and Tolerability
Disease Control Rate
Duration of Response
Progression-Free Survival
Overall Survival
Immunogenicity
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