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

NCT03774979 | Unknown Phase 1

• 1 other identifier: SHR-1701-I-102
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Solid Tumor

Keywords

SHR-1701; Solid tumor; Metastatic or locally advanced solid tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Clinical expansion Part: Safety of SHR-1701

  Up to 4 weeks after last treatment

• Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1

  Up to 6 weeks

• Clinical expansion Part: Duration of Response （DOR）per RECIST1.1

  Up to 6 weeks

• Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1

  12months (anticipated)

Study Arms (1)

SHR-1701

EXPERIMENTAL

intravenous infusion

Drug: SHR-1701

Interventions

SHR-1701 DRUG

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.

SHR-1701

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (16)

Anhui Chest Hospital-Departmen of Tumor Radiotherapy

Hefei, Anhui, China

Location

The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center

Guangzhou, Guangzhou, China

Location

Xinxiang Central Hospital-Department of Respiratory Physicians

Xinxiang, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology

Zhengzhou, Henan, China

Location

Cancer Hospital of Hunan Province

Changsha, Hunan, China

Location

Hunan Cancer Hospital-Gynecologic Oncology

Changsha, Hunan, China

Location

Jangsu Cancer Hospital

Nanjing, Jiangsu, China

Location

The First Rffiurted Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of China Medical University-Department of Oncology

Shenyang, Liaoning, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Location

Beijing Chest Hospital,Capital Medical University-Integrated Department

Beijing, China

Location

Tumor Hospital of the Chinese Academy of Medical Sciences

Beijing, China

Location

ChongQing Cancer Hospital-gynecologic oncology

Chongqing, China

Location

Chongqing Cancer Hospital

Chongqing, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

SHR-1701

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jifeng Feng, MD

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 13, 2018
• Study Start: January 24, 2019
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)