NCT05020925

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

August 23, 2021

Last Update Submit

August 23, 2021

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal CarcinomaSHR-1701Famitinib

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • DoR

    up to approximately 2 years (anticipated)

  • DCR

    up to approximately 2 years (anticipated)

  • PFS

    up to approximately 2 years (anticipated)

  • OS

    up to approximately 2 years (anticipated)

  • AEs

    up to approximately 2 years (anticipated)

Study Arms (1)

SHR-1701 plus Famitinib

EXPERIMENTAL

SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy

Drug: SHR-1701Drug: Famitinib

Interventions

SHR-1701DRUG

Intravenous (IV) on Day 1 of each cycle

Also known as: SHR-1701 Injection
SHR-1701 plus Famitinib
FamitinibDRUG

Famitinib, po, qd

Also known as: SHR-1020
SHR-1701 plus Famitinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of Guangzhou Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

SHR-1701famitinib

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Qing Yang, MD

CONTACT

+86-021-15705155017qing.yang@hengrui.com

Yanbo Liu, MB

CONTACT

+86-021-18036614138yanbo.liu@hengrui.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 25, 2021

Study Start

September 1, 2021

Primary Completion

May 1, 2022

Study Completion

February 1, 2024

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)