NCT05193604

A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma

Phase I Clinical Trial to Evaluate the Tolerability and Safety of TQB2858 Injection in Subjects With Metastatic Pancreatic Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is divided into three phases: single-dose exploration, combination dosage exploration and cohort expansion. The Single-dose exploration stage aims to evaluate the tolerability of TQB2858 injection in subjects with advanced pancreatic carcinoma. The Combination dosage exploration stage aims to evaluate the tolerance of TQB2858 injection combined with chemotherapy in patients with metastatic pancreatic cancer. The cohort expansion phase aims to evaluate the preliminary efficacy of TQB2858 injection combined with gemcitabine, albumin paclitaxel, and with or without anlotinib in patients with metastatic pancreatic cancer，and to explore treatment-related biomarkers.

Conditions

• Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	TQB2858 injection	TQB2858 injection is a programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β bispecific antibody.
DRUG	Anlotinib Hydrochloride Capsule	Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
DRUG	Gemcitabine hydrochloride for injection	Chemotherapy medicine for metastatic pancreatic cancer
DRUG	Paclitaxel for injection (albumin bound)	Chemotherapy medicine for metastatic pancreatic cancer

Timeline

• Start date: 2022-03-24
• Primary completion: 2023-11-27
• Completion: 2023-11-27
• First posted: 2022-01-18
• Last updated: 2023-12-08

Locations

1 site across 1 country: China