NCT03995472

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in combination with SHR-1316 in patients with advanced malignancies and to provide a recommended dose (RP2D) for subsequent clinical studies.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2020

Typical duration for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 9, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

February 14, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

May 9, 2019

Last Update Submit

September 26, 2023

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (3)

  • Dose-limiting toxicity and Maximum tolerated dose

    Dose-limiting toxicity and Maximum tolerated dose in patients with advanced tumors treated by SHR-1501 combined with SHR-1316.

    Approximately 42 Days.

  • Recommended Phase 2 dose (RP2D)

    Recommended Phase 2 dose (RP2D) based on comprehensive evaluation

    Approximately 2 years

  • Adverse event/Serious adverse event

    Incidence/severity of adverse events/serious adverse events (rated based on CTC AE v5.0)

    Approximately 2 years

Secondary Outcomes (25)

  • Pharmacokinetic (PK)

    Approximately 2 years

  • Pharmacokinetic (PK)

    Approximately 2 years

  • Pharmacokinetic (PK)

    Approximately 2 years

  • Pharmacokinetic (PK)

    Approximately 2 years

  • Pharmacokinetic (PK)

    Approximately 2 years

  • +20 more secondary outcomes

Study Arms (3)

SHR-1501 and SHR-1316 dose escalation

EXPERIMENTAL

SHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously.

Drug: SHR-1501Drug: SHR-1316

SHR-1501 and SHR-1316 dose expansion

EXPERIMENTAL

SHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously.

Drug: SHR-1501Drug: SHR-1316

SHR-1501 and SHR-1316 Indication expansion

EXPERIMENTAL

SHR-1501 given subcutaneously with a recommended dose. SHR-1316 given intravenously.

Drug: SHR-1501Drug: SHR-1316

Interventions

SHR-1501DRUG

Administered subcutaneously

SHR-1501 and SHR-1316 Indication expansionSHR-1501 and SHR-1316 dose escalationSHR-1501 and SHR-1316 dose expansion
SHR-1316DRUG

Administered intravenously

SHR-1501 and SHR-1316 Indication expansionSHR-1501 and SHR-1316 dose escalationSHR-1501 and SHR-1316 dose expansion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All Patients All patients must meet all the following criteria to be eligible to participate:
  • Voluntarily participate in this clinical study, understand the research procedure and be able to sign informed consent in writing;
  • Subjects must be willing and able to follow the research protocol;
  • Aged 18-75 years old when the informed consent form is signed;
  • Have a histologically or cytologically confirmed diagnosis of advanced or metastatic tumor malignancy;
  • Patients' malignancies must be relapsed or refractory to standard treatment, or patients cannot tolerate standard treatment, or patients have actively refused standard therapy;
  • FFPE tumor tissue or unstained slides of tumor sample must be obtained from patients enrolled in the dose expansion or indication expansion stage, both preserved samples collected within 6 months before the first dose (or up to 12 months prior to the first dose) and fresh samples (preferred) are acceptable;
  • Eastern Cooperative Oncology Group ECOG PS score of 0-1;
  • Have a life expectancy of ≥ 12 weeks;
  • Adequate organ function defined according to the protocol, These results should be completed within 14 days prior to the first study treatment:
  • Non-surgically sterilized women of childbearing age or male subjects are required to consent to the use of at least one medically approved contraceptive (eg intrauterine devices, contraceptives or condoms) is performed during the study treatment period and within 3 months of the end of the study treatment period.

You may not qualify if:

  • Patients with cancerous meningitis (ie meningeal metastasis);
  • Patients with active central nervous system (CNS) metastasis.
  • Spinal cord compression that cannot be radically treated with surgery and/or radiotherapy cannot be enrolled.
  • Patients with double cancer or more serious cancer;
  • Patients with a history of autoimmune diseases;
  • Significant clinical significance in the history of cardiovascular disease;
  • Arterial/venous thrombosis events such as cerebrovascular accidents deep vein thrombosis and pulmonary embolism within 6 months prior to first administration;
  • Have a history of immunodeficiency including HIV infection;
  • Active hepatitis B or hepatitis C patients;
  • Patients have undergone major surgery within 28 days prior to the first dose (except for diagnostics);
  • Those who used a live attenuated vaccine within 4 weeks prior to the first dose or expect a live attenuated vaccine during the study period;
  • Those who received other clinical trials within 4 weeks prior to the first study;
  • Those who received systemic immunosuppressive therapy within 2 weeks prior to the first study dose;
  • Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;
  • A history of severe allergic reactions to other monoclonal antibody/fusion protein drugs;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sydney Southwest Private Hospital

Liverpool, New South Wales, 2170, Australia

Location

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

Location

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, 4101, Australia

Location

John Flynn Private Hospital

Tugun, Queensland, 4224, Australia

Location

Guangdong General Hospital & Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, 510080, China

Location

Study Officials

  • Yilong Wu, MD

    Guangdong General Hospital & Guangdong Academy of Medical Sciences

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 9, 2019

First Posted

June 24, 2019

Study Start

February 14, 2020

Primary Completion

January 12, 2023

Study Completion

January 12, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

AU(4)CN(1)