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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05020925
• Other study ID #: SHR-1701-II-203-NPC
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2021
• Est. completion date: February 2024

Study information

• Verified date: August 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Qing Yang, MD
• Phone: +86-021-15705155017
• Email: qing.yang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2024
• Est. primary completion date: May 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 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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• SHR-1701
Intravenous (IV) on Day 1 of each cycle
• Famitinib
Famitinib, po, qd

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