Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors

Phase 1

• Conditions: Tumor
• Interventions: Drug: SHR-1316

• Registration Number: NCT03474289
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

The purpose of this study is to access the safety and tolerability of the study drug known as SHR-1316 in metastatic/advanced malignancies

Detailed Description

This is an open-label, non-randomized, dose escalation/expansion phase I study, SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Study Timeline

• Status Verified: 2018-03
• Study Start: 2018-03-01
• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-03-15
• Last Update Submitted: 2018-03-15
• Study First Posted: 2018-03-22
• Last Update Posted: 2018-03-22
• Primary Completion: 2019-01-30
• Study Completion: 2019-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1. Male or female ≥18 years of age
2. Subjects with confirmed advanced malignancies (histologically or cytologically)
3. ECOG Performance status of 0 or 1
4. Adequate organ functions
5. Life expectancy ≥12 weeks;

Exclusion Criteria

1. Subjects with active autoimmune disease.
2. Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 4 weeks of the first dose of trial treatment
3. Previous received PD-1 or PD-L1 therapy
4. Known Active central nervous system (CNS) metastases
5. Known Clinically significant cardiovascular condition
6. Active infection or an unexplained fever >38.5°C
7. History of immunodeficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escalation	SHR-1316	SHR-1316 administrated intravenously(IV) at protocol defined dose levels
Expansion	SHR-1316	SHR-1316 administrated IV in advanced solid tumors and selected tumor type

Primary Outcome Measures

Name	Time	Method
Adverse Events	at the end of cycle one(each cycle is 21 days)	incidence and severity of treatment-related adverse events
Dose-limiting toxicities (DLTs)	at the end of cycle one(each cycle is 21 days)	Number of participants with DLTs

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China