SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04282070

Collaborator

(none)

Enrollment

Location

Arms

32.6

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: SHR-1701 Drug: Gemcitabine Drug: Cisplatin Drug: Albumin Paclitaxel	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 27, 2020

Anticipated Primary Completion Date :

Apr 16, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SHR-1701 (Arm A) SHR-1701 for R/M NPC failure after platinum-based chemotherapy	Drug: SHR-1701 Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial. Other Names: SHR-1701 Injection
Experimental: SHR-1701 (Arm B) SHR-1701 for R/M NPC failure after anti PD-1/PD-L1 antibody therapy	Drug: SHR-1701 Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial. Other Names: SHR-1701 Injection
Experimental: SHR-1701 plus Gemcitabine and Cisplatin (Arm C) SHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC	Drug: SHR-1701 Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial. Other Names: SHR-1701 Injection Drug: Gemcitabine Maximum 6 cycles for combined therapy. Other Names: Gemcitabine Hydrochloride for Injection Drug: Cisplatin Maximum 6 cycles for combined therapy. Other Names: Cisplatin Injection
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	Drug: SHR-1701 Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial. Other Names: SHR-1701 Injection Drug: Albumin Paclitaxel Maximum 6 cycles for combined therapy. Other Names: nab-Paclitaxel

Outcome Measures

Primary Outcome Measures

Toxicity Toxicity [up to 2 years]
Number of participants with adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Objective Response Rate (ORR) per RECIST 1.1 [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.
Progression-free Survival (PFS) per RECIST 1.1 [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.
Disease Control Rate (DCR) per RECIST 1.1 [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.
Immunogenicity of SHR-1701 [up to 2 years]
anti SHR-1603 antibodies (ADA)
Overall Survival (OS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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