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

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

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

Study Overview

• Status: Unknown
• Conditions: Tumor
• Intervention / Treatment: Drug: SHR-1316

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 Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gang Chen, PhD; Phone Number: +86 (021)50118422; Email: chen_gang@shhrp.com
• Study Contact Backup: Name: Ying Tian; Email: tianying@shhrp.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Escalation; SHR-1316 administrated intravenously(IV) at protocol defined dose levels	Drug: SHR-1316; Monotherapy; Other Names: HTI-1088
EXPERIMENTAL: Expansion; SHR-1316 administrated IV in advanced solid tumors and selected tumor type	Drug: SHR-1316; Monotherapy; Other Names: HTI-1088

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ANTICIPATED): January 30, 2019
• Study Completion (ANTICIPATED): October 31, 2019

Study Registration Dates

• First Submitted: March 11, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (ACTUAL): March 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SHR-1316-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No