Brief Title
SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
Official Title
A Phase Ib, Open-label Trial to Investigate the Safety and Tolerability of SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
Brief Summary
This is an open label, phase Ib Study of SHR-1701 in patients with recurrent/metastatic
nasopharyngeal carcinoma(R/M NPC).
Detailed Description
The main purpose of this study is to assess the safety and tolerability of SHR-1701 in
patients with R/M NPC. The secondary purpose is to assess the anti-tumor activity and
immunogenicity of SHR-1701 in R/M NPC.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Toxicity Toxicity
Secondary Outcome
Objective Response Rate (ORR) per RECIST 1.1
Condition
Nasopharyngeal Carcinoma
Intervention
SHR-1701
Study Arms / Comparison Groups
SHR-1701
Description: R/M NPC subjects failure after 2 lines of chemotherapy or after anti PD-1/PD-L1 antibody therapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
March 27, 2020
Completion Date
December 15, 2022
Primary Completion Date
April 16, 2021
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma
- Subjects failure after 2 lines of chemotherapy or failure from anti-PD-1/PD-L1
antibody therapy.
- 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.
- 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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
, +86-021-61052512, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04282070
Organization ID
SHR-1701-I-103
Responsible Party
Sponsor
Study Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor
, ,
Verification Date
December 2020