- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04282070
SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
December 19, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase Ib, Open-label Trial to Investigate the Safety and Tolerability of SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
This is an open label, phase Ib Study of SHR-1701 in patients with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
91
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Cancer Hospital of Guangzhou Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR-1701 (Arm A)
SHR-1701 for R/M NPC failure after platinum-based chemotherapy
|
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Other Names:
|
Experimental: SHR-1701 (Arm B)
SHR-1701 for R/M NPC failure after anti PD-1/PD-L1 antibody therapy
|
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Other Names:
|
Experimental: SHR-1701 plus Gemcitabine and Cisplatin (Arm C)
SHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC
|
Maximum 6 cycles for combined therapy.
Other Names:
Maximum 6 cycles for combined therapy.
Other Names:
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Other Names:
|
Experimental: 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
|
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Other Names:
Maximum 6 cycles for combined therapy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity Toxicity
Time Frame: up to 2 years
|
Number of participants with adverse events as assessed by CTCAE v5.0
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR) per RECIST 1.1
Time Frame: up to 2 years
|
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 2 years
|
Progression-free Survival (PFS) per RECIST 1.1
Time Frame: up to 2 years
|
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 2 years
|
Disease Control Rate (DCR) per RECIST 1.1
Time Frame: up to 2 years
|
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 2 years
|
Immunogenicity of SHR-1701
Time Frame: up to 2 years
|
anti SHR-1603 antibodies (ADA)
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up to 2 years
|
Overall Survival (OS)
Time Frame: up to 2 years
|
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 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2020
Primary Completion (Anticipated)
April 16, 2022
Study Completion (Anticipated)
December 15, 2022
Study Registration Dates
First Submitted
February 18, 2020
First Submitted That Met QC Criteria
February 20, 2020
First Posted (Actual)
February 24, 2020
Study Record Updates
Last Update Posted (Actual)
December 21, 2021
Last Update Submitted That Met QC Criteria
December 19, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
- Cisplatin
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- SHR-1701-I-103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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