NCT02492789

A Trial to Evaluate Safety and Tolerability of INCSHR01210 in Cancer Patients

An Open-Label, Multicenter, Nonrandomized, Dose-Escalation and Tumor-Expansion Phase 1 Study to Evaluate the Safety and Tolerability of INCSHR01210 (Formerly SHR-1210) in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Atridia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, non-randomized, dose escalation and tumor-expansion phase I trial to evaluate safety and tolerability of INCSHR01210 in patients with advanced solid tumors. The trial will enroll subjects with advanced solid tumor who have failed current standard anti-tumor therapies.

Conditions

• Solid Tumors and Hematologic Malignancy

Interventions

Type	Name	Description
BIOLOGICAL	INCSHR01210 injection	Part1: INCSHR01210 injection at a dose of 1, 3 or 10 mg/kg is administered every 2 weeks (3+3,q2w, except in the first cycle, in which subjects will be only dosed once on Day 1 for PK samplings and dose limiting toxicity observation). Response is assessed by every 2 cycles (4 weeks each cycle) by using irRECIST. Part2: Additional patients (200mg dose cohorts will be enrolled in Part 2, depending on the data outcomes in Part 1, to further explore preliminarily clinical benefits of INCSHR01210 as well as the other objectives of the study.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-03-01
• Completion: 2019-07-05
• First posted: 2015-07-09
• Last updated: 2019-09-30

Locations

5 sites across 1 country: Australia