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

Tumor Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03474289
• Other study ID #: SHR-1316-I-101
• Status: Recruiting
• Phase: Phase 1
• First received: March 11, 2018
• Last updated: March 15, 2018
• Start date: March 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Gang Chen, PhD
• Phone: +86 (021)50118422
• Email: chen_gang[@]shhrp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: October 31, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tumor

Intervention

Drug:
• SHR-1316
Monotherapy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	incidence and severity of treatment-related adverse events	at the end of cycle one(each cycle is 21 days)
Primary	Dose-limiting toxicities (DLTs)	Number of participants with DLTs	at the end of cycle one(each cycle is 21 days)