SHR-1701 in Metastatic or Locally Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title: A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Status Recruiting

Clinical Trial Summary

The main purpose of this Phase I study is to access the safety and tolerability of SHR-1701 at different dose levels. It is hoped to find out the recommended dose for Phase II/III.

Clinical Trial Description

This is a Phase I, open-label trial in patients with metastatic or locally advanced solid tumor. There are three parts of the study: a dose-escalation part, a dose-expansion part, and a clinical expansion part. Dose escalation part is a standard "3+3" cohort design, for which 3 or 6 subjects will be enrolled at each dose level depending on the occurrence of dose-limiting toxicities (DLTs). Dose-expansion means that at least 10 subjects (included subjects of the dose-escalation part) will be selected in 2 - 3 dose levels to focus on the pharmacokinetics (PK) / pharmacodynamic (PD) features. After determination of the recommended dose for Phase II (RP2D), clinical expansion will be opened. Many more subjects will be invited to take part in the study and received the study drug at the RP2D. Additional purpose of the study is to find out whether the study drug has anti-tumor effects. ;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

• NCT number: NCT03710265
• Study type: Interventional
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Linna Wang, MD
• Phone: +86-10-67166319
• Email: Linna.wang@hengrui.com
• Status: Recruiting
• Phase: Phase 1
• Start date: November 20, 2018
• Completion date: December 31, 2022