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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: SHR-1701; Drug: Famitinib

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qing Yang, MD; Phone Number: +86-021-15705155017; Email: qing.yang@hengrui.com
• Study Contact Backup: Name: Yanbo Liu, MB; Phone Number: +86-021-18036614138; Email: yanbo.liu@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Cancer Hospital of Guangzhou Sun Yat-sen University
      • Contact: Li Zhang, M.D.; Phone Number: 86-020-87342288; Email: zhangli6@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1701 plus Famitinib; SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy	Drug: SHR-1701; Intravenous (IV) on Day 1 of each cycle; Other Names: SHR-1701 Injection; Drug: Famitinib; Famitinib, po, qd; Other Names: SHR-1020

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to approximately 2 years (anticipated)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DoR	Duration of Response per RECIST 1.1	up to approximately 2 years (anticipated)
DCR	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 approximately 2 years (anticipated)
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.	up to approximately 2 years (anticipated)
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 approximately 2 years (anticipated)
AEs	Number of participants with adverse events as assessed by CTCAE v5.0	up to approximately 2 years (anticipated)

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: SHR-1701; Famitinib; Nasopharyngeal Carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: SHR-1701-II-203-NPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No