SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
NCT ID: NCT04282070
Last Updated: 2021-12-21
Study Results
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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UNKNOWN
PHASE1
91 participants
INTERVENTIONAL
2020-03-27
2022-12-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SHR-1701 (Arm A)
SHR-1701 for R/M NPC failure after platinum-based chemotherapy
SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
SHR-1701 (Arm B)
SHR-1701 for R/M NPC failure after anti PD-1/PD-L1 antibody therapy
SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
SHR-1701 plus Gemcitabine and Cisplatin (Arm C)
SHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC
SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Gemcitabine
Maximum 6 cycles for combined therapy.
Cisplatin
Maximum 6 cycles for combined therapy.
SHR-1701 plus Albumin Paclitaxel (Arm D)
SHR-1701+Albumin Paclitaxel for R/M NPC failure after first line anti PD-1/PD-L1 antibody therapy
SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Albumin Paclitaxel
Maximum 6 cycles for combined therapy.
Interventions
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SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Gemcitabine
Maximum 6 cycles for combined therapy.
Cisplatin
Maximum 6 cycles for combined therapy.
Albumin Paclitaxel
Maximum 6 cycles for combined therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects failure after platinum-based chemotherapy; failure from anti-PD-1/PD-L1 antibody therapy; Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment; failure from first line 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.
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.
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital of Guangzhou Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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SHR-1701-I-103
Identifier Type: -
Identifier Source: org_study_id