A Study of SHR-1501 in Patients With Advanced Tumors

NCT04025957 | Completed Phase 1

• 1 other identifier: SHR-1501-I-102
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in patients with advanced malignancies .

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity

  Dose-limiting toxicity in patients with advanced tumors treated by SHR-1501.

  Approximately 2 years

• Maximum tolerated dose

  Maximum tolerated dose in patients with advanced tumors treated by SHR-1501.

  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 (21)

• 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

Study Arms (2)

SHR-1501 dose escalation

EXPERIMENTAL

SHR-1501 given subcutaneously

Drug: SHR-1501

SHR-1501 dose expansion

EXPERIMENTAL

SHR-1501 given subcutaneously

Drug: SHR-1501

Interventions

SHR-1501 DRUG

Administered subcutaneously

SHR-1501 dose escalation; SHR-1501 dose expansion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 18-70 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;
• 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 primary cancers;
• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Cancer hospital, Chinese academy of medical sciences

Beijing, 100021, China

Location

Study Officials

• Jing Huang, MD

  Cancer Institute and Hospital, Chinese 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: July 14, 2019
• First Posted: July 19, 2019
• Study Start: October 30, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: September 28, 2023

Record last verified: 2020-07

Locations

CN (1)