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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03774979
• Other study ID #: SHR-1701-I-102
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 24, 2019
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 193
• Est. completion date: December 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Clinical expansion Part: Safety of SHR-1701	Number of subjects who occurs treatment-related Adverse Events(AEs)	Up to 4 weeks after last treatment
Secondary	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
Secondary	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
Secondary	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)