SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT05020925

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2024-02-29

Brief Summary

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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).

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-1701 plus Famitinib

SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy

Group Type EXPERIMENTAL

SHR-1701

Intervention Type DRUG

Intravenous (IV) on Day 1 of each cycle

Famitinib

Intervention Type DRUG

Famitinib, po, qd

Interventions

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SHR-1701

Intravenous (IV) on Day 1 of each cycle

Intervention Type DRUG

Famitinib

Famitinib, po, qd

Intervention Type DRUG

Other Intervention Names

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SHR-1701 Injection SHR-1020

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Hospital of Guangzhou Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Qing Yang, MD

Role: CONTACT

+86-021-15705155017

Yanbo Liu, MB

Role: CONTACT

+86-021-18036614138

Facility Contacts

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Li Zhang, M.D.

Role: primary

86-020-87342288

Other Identifiers

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SHR-1701-II-203-NPC

Identifier Type: -

Identifier Source: org_study_id

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