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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05020925
Other study ID # SHR-1701-II-203-NPC
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 2021
Est. completion date February 2024

Study information

Verified date August 2021
Source Jiangsu HengRui Medicine Co., Ltd.
Contact Qing Yang, MD
Phone +86-021-15705155017
Email qing.yang@hengrui.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open label, multi-center, phase I/II study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date February 2024
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma - Subjects failure after platinum-based chemotherapy and anti-PD-1/PD-L1 antibody therapy; - Able and willing to provide signed informed consent form, and able to comply with all procedures. - 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: - 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SHR-1701
Intravenous (IV) on Day 1 of each cycle
Famitinib
Famitinib, po, qd

Locations

Country Name City State
China Cancer Hospital of Guangzhou Sun Yat-sen University Guangzhou Guangdong

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 ORR ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. up to approximately 2 years (anticipated)
Secondary DoR Duration of Response per RECIST 1.1 up to approximately 2 years (anticipated)
Secondary DCR DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1. up to approximately 2 years (anticipated)
Secondary PFS PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first. up to approximately 2 years (anticipated)
Secondary OS Overall Survival is defined as the time from registration to death due to any cause, or censored at date last known alive. OS will be measured by the Method of Kaplan and Meier. up to approximately 2 years (anticipated)
Secondary AEs Number of participants with adverse events as assessed by CTCAE v5.0 up to approximately 2 years (anticipated)
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