Back to results

SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SHR-1701

Gemcitabine

Cisplatin

Albumin Paclitaxel

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma

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; 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

Sites / Locations

Cancer Hospital of Guangzhou Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

SHR-1701 (Arm A)

SHR-1701 (Arm B)

SHR-1701 plus Gemcitabine and Cisplatin (Arm C)

SHR-1701 plus Albumin Paclitaxel (Arm D)

Arm Description

SHR-1701 for R/M NPC failure after platinum-based chemotherapy

SHR-1701 for R/M NPC failure after anti PD-1/PD-L1 antibody therapy

SHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC

SHR-1701+Albumin Paclitaxel for R/M NPC failure after first line anti PD-1/PD-L1 antibody therapy

Outcomes

Primary Outcome Measures

Toxicity Toxicity

Number of participants with adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Objective Response Rate (ORR) per RECIST 1.1

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.

Progression-free Survival (PFS) per RECIST 1.1

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.

Disease Control Rate (DCR) per RECIST 1.1

DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.

Immunogenicity of SHR-1701

anti SHR-1603 antibodies (ADA)

Overall Survival (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.

Full Information

NCT ID

NCT04282070

First Posted

February 18, 2020

Last Updated

December 19, 2021

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04282070

Brief Title

SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Official Title

A Phase Ib, Open-label Trial to Investigate the Safety and Tolerability of SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 27, 2020 (Actual)

Primary Completion Date

April 16, 2022 (Anticipated)

Study Completion Date

December 15, 2022 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open label, phase Ib Study of SHR-1701 in patients with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SHR-1701 (Arm A)

Arm Type

Experimental

Arm Description

SHR-1701 for R/M NPC failure after platinum-based chemotherapy

Arm Title

SHR-1701 (Arm B)

Arm Type

Experimental

Arm Description

SHR-1701 for R/M NPC failure after anti PD-1/PD-L1 antibody therapy

Arm Title

SHR-1701 plus Gemcitabine and Cisplatin (Arm C)

Arm Type

Experimental

Arm Description

SHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC

Arm Title

SHR-1701 plus Albumin Paclitaxel (Arm D)

Arm Type

Experimental

Arm Description

SHR-1701+Albumin Paclitaxel for R/M NPC failure after first line anti PD-1/PD-L1 antibody therapy

Intervention Type

Drug

Intervention Name(s)

SHR-1701

Other Intervention Name(s)

SHR-1701 Injection

Intervention Description

Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemcitabine Hydrochloride for Injection

Intervention Description

Maximum 6 cycles for combined therapy.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Cisplatin Injection

Intervention Description

Maximum 6 cycles for combined therapy.

Intervention Type

Drug

Intervention Name(s)

Albumin Paclitaxel

Other Intervention Name(s)

nab-Paclitaxel

Intervention Description

Maximum 6 cycles for combined therapy.

Primary Outcome Measure Information:

Title

Toxicity Toxicity

Description

Number of participants with adverse events as assessed by CTCAE v5.0

Time Frame

up to 2 years

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) per RECIST 1.1

Description

Time Frame

up to 2 years

Title

Progression-free Survival (PFS) per RECIST 1.1

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 2 years

Title

Disease Control Rate (DCR) per RECIST 1.1

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 2 years

Title

Immunogenicity of SHR-1701

Description

anti SHR-1603 antibodies (ADA)

Time Frame

up to 2 years

Title

Overall Survival (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 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Cancer Hospital of Guangzhou Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

We'll reach out to this number within 24 hrs