NCT03474289

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

March 11, 2018

Last Update Submit

March 15, 2018

Conditions

Tumor

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (2)

Escalation

EXPERIMENTAL

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

Drug: SHR-1316

Expansion

EXPERIMENTAL

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

Drug: SHR-1316

Interventions

SHR-1316DRUG

Monotherapy

Also known as: HTI-1088
EscalationExpansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Xichun Hu

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Chen, PhD

CONTACT

+86 (021)50118422chen_gang@shhrp.com

Ying Tian

CONTACT

tianying@shhrp.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2018

First Posted

March 22, 2018

Study Start

March 1, 2018

Primary Completion

January 30, 2019

Study Completion

October 31, 2019

Last Updated

March 22, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)