SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors

A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications

The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: SHR-1701

Detailed Description

This is a Phase I, open-label, multiple-ascending dose trial. Study consists of dose-escalation part in subjects with metastatic or locally advanced solid tumors, and expansion part with selected indications.

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Chest Hospital,Capital Medical University-Integrated Department
  • Beijing, China
    • Tumor Hospital of the Chinese Academy of Medical Sciences
  • Chongqing, China
    • ChongQing Cancer Hospital-gynecologic oncology
  • Chongqing, China
    • Chongqing Cancer Hospital
  • Anhui
    • Hefei, Anhui, China
      • Anhui Chest Hospital-Departmen of Tumor Radiotherapy
  • Guangzhou
    • Guangzhou, Guangzhou, China
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center
  • Henan
    • Xinxiang, Henan, China
      • Xinxiang Central Hospital-Department of Respiratory Physicians
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology
  • Hunan
    • Changsha, Hunan, China
      • Cancer Hospital of Hunan Province
    • Changsha, Hunan, China
      • Hunan Cancer Hospital-Gynecologic Oncology
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jangsu Cancer Hospital
    • Suzhou, Jiangsu, China, 215006
      • The First Rffiurted Hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The first affiliated Hospital of Nanchang University
  • Liaoning
    • Shenyang, Liaoning, China
      • The First Hospital of China Medical University-Department of Oncology
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able and willing to provide signed informed consent form, and able to comply with all procedures.
• Histologically or cytologically proven metastatic or locally advanced solid tumors.
• Male or female subjects aged 18-75 years.
• Life expectancy >= 12 weeks as judged by the Investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
• Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Adequate hematological, hepatic and renal function as defined in the protocol

Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

• Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
• Anticancer treatment within 28 days before the first dose of study drug.
• Major surgery within 28 days before start of trial treatment.
• Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
• With any active autoimmune disease or history of autoimmune disease.
• With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
• Clinically significant cardiovascular and cerebrovascular diseases
• History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
• Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
• Receipt of any organ transplantation, including allogeneic stem-cell transplantation

Other protocol-defined exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1701; intravenous infusion	Drug: SHR-1701; Subjects will receive an intravenous infusion of SHR-1701 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies.	Number of Subjects who occurs dose-limiting toxicity (DLTs).	Up to 3/4 weeks.
Clinical expansion Part: Objective Response Rate（ORR）	ORR is define as the percentage of participants in the analysis population who havea Complete Response(CR:Disappearance of all target lesions)or a Partial Response(PR :30% decrease in the sum of diameter of target lesions) per RECIST 1.1.	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical expansion Part: Safety of SHR-1701	Number of subjects who occurs treatment-related Adverse Events(AEs）	Up to 4 weeks after last treatment
Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1	DCR is define as the percentage of participants in the analysis population who have a CR,PR or SD per RECIST 1.1.	Up to 6 weeks
Clinical expansion Part: Duration of Response （DOR）per RECIST1.1	DOR is define as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1	Up to 6 weeks
Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1	12months (anticipated)

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Jifeng Feng, MD, Jiangsu Cancer Institute & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Solid tumor; SHR-1701; Metastatic or locally advanced solid tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-1701-I-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No