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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-1701
Famitinib
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, SHR-1701, Famitinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital of Guangzhou Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR-1701 plus Famitinib

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

DoR
Duration of Response per RECIST 1.1
DCR
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
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.
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.
AEs
Number of participants with adverse events as assessed by CTCAE v5.0

Full Information

First Posted
August 23, 2021
Last Updated
August 23, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05020925
Brief Title
SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
Official Title
A Phase I/II, Open-label, Multi-center Trial to Investigate the Efficacy and Safety of SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma, SHR-1701, Famitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR-1701 plus Famitinib
Arm Type
Experimental
Arm Description
SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy
Intervention Type
Drug
Intervention Name(s)
SHR-1701
Other Intervention Name(s)
SHR-1701 Injection
Intervention Description
Intravenous (IV) on Day 1 of each cycle
Intervention Type
Drug
Intervention Name(s)
Famitinib
Other Intervention Name(s)
SHR-1020
Intervention Description
Famitinib, po, qd
Primary Outcome Measure Information:
Title
ORR
Description
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.
Time Frame
up to approximately 2 years (anticipated)
Secondary Outcome Measure Information:
Title
DoR
Description
Duration of Response per RECIST 1.1
Time Frame
up to approximately 2 years (anticipated)
Title
DCR
Description
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
Time Frame
up to approximately 2 years (anticipated)
Title
PFS
Description
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.
Time Frame
up to approximately 2 years (anticipated)
Title
OS
Description
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.
Time Frame
up to approximately 2 years (anticipated)
Title
AEs
Description
Number of participants with adverse events as assessed by CTCAE v5.0
Time Frame
up to approximately 2 years (anticipated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Yang, MD
Phone
+86-021-15705155017
Email
qing.yang@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanbo Liu, MB
Phone
+86-021-18036614138
Email
yanbo.liu@hengrui.com
Facility Information:
Facility Name
Cancer Hospital of Guangzhou Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang, M.D.
Phone
86-020-87342288
Email
zhangli6@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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