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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03474289
Collaborator
(none)
134
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
134 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors
Actual Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Jan 30, 2019
Anticipated Study Completion Date :
Oct 31, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [at the end of cycle one(each cycle is 21 days)]

      incidence and severity of treatment-related adverse events

    2. Dose-limiting toxicities (DLTs) [at the end of cycle one(each cycle is 21 days)]

      Number of participants with DLTs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Shanghai Cancer Center Shanghai China

    Sponsors and Collaborators

    • Jiangsu HengRui Medicine Co., Ltd.

    Investigators

    • Principal Investigator: Xichun Hu, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiangsu HengRui Medicine Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03474289
    Other Study ID Numbers:
    • SHR-1316-I-101
    First Posted:
    Mar 22, 2018
    Last Update Posted:
    Mar 22, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 22, 2018