SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Cisplatin; Drug: Albumin Paclitaxel; Drug: SHR-1701; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04282070

SHR-1701-I-103

Details and patient eligibility

About

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

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 4 patient groups

SHR-1701 (Arm A)

Experimental group

Description:

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

Treatment:

Drug: SHR-1701

SHR-1701 (Arm B)

Experimental group

Description:

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

Treatment:

Drug: SHR-1701

SHR-1701 plus Gemcitabine and Cisplatin (Arm C)

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: SHR-1701

Drug: Cisplatin

SHR-1701 plus Albumin Paclitaxel (Arm D)

Experimental group

Description:

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

Treatment:

Drug: SHR-1701

Drug: Albumin Paclitaxel