SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04282070
• Other study ID #: SHR-1701-I-103
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 27, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 91
• Est. completion date: December 15, 2022
• Est. primary completion date: April 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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.
• Gemcitabine
Maximum 6 cycles for combined therapy.
• Cisplatin
Maximum 6 cycles for combined therapy.
• Albumin Paclitaxel
Maximum 6 cycles for combined therapy.

Locations

Country	Name	City	State
China	Cancer Hospital of Guangzhou Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity Toxicity	Number of participants with adverse events as assessed by CTCAE v5.0	up to 2 years
Secondary	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.	up to 2 years
Secondary	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.	up to 2 years
Secondary	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.	up to 2 years
Secondary	Immunogenicity of SHR-1701	anti SHR-1603 antibodies (ADA)	up to 2 years
Secondary	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.	up to 2 years