Clinical trial NCT03774979: SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Keywords: SHR-1701
Solid tumor
Metastatic or locally advanced solid tumors
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-13
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies.
timeFrame: Up to 3/4 weeks.
measure: Clinical expansion Part: Objective Response Rate（ORR）
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Clinical expansion Part: Safety of SHR-1701
timeFrame: Up to 4 weeks after last treatment
measure: Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1
timeFrame: Up to 6 weeks
measure: Clinical expansion Part: Duration of Response （DOR）per RECIST1.1
timeFrame: Up to 6 weeks
measure: Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1
timeFrame: 12months (anticipated)
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Chest Hospital-Departmen of Tumor Radiotherapy
state: Anhui
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center
state: Guangzhou
city: Xinxiang
country: China
facility: Xinxiang Central Hospital-Department of Respiratory Physicians
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology
state: Henan
city: Changsha
country: China
facility: Cancer Hospital of Hunan Province
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital-Gynecologic Oncology
state: Hunan
city: Nanjing
country: China
facility: Jangsu Cancer Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Rffiurted Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital Of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: The First Hospital of China Medical University-Department of Oncology
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Beijing Chest Hospital,Capital Medical University-Integrated Department
city: Beijing
country: China
facility: Tumor Hospital of the Chinese Academy of Medical Sciences
city: Chongqing
country: China
facility: ChongQing Cancer Hospital-gynecologic oncology
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
Study officials:
affiliation: Jiangsu Cancer Institute & Hospital
name: Jifeng Feng, MD
role: PRINCIPAL_INVESTIGATOR
References: