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

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Tumor

Treatments: Drug: SHR-1316

Study type: Interventional

Funder types: Industry

Identifiers

NCT03474289

SHR-1316-I-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Escalation

Experimental group

Description:

SHR-1316 administrated intravenously(IV) at protocol defined dose levels

Treatment:

Drug: SHR-1316

Expansion

Experimental group

Description:

SHR-1316 administrated IV in advanced solid tumors and selected tumor type

Treatment:

Drug: SHR-1316