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Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC

Primary Purpose

Nasopharyngeal Carcinoma by AJCC V8 Stage

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HLX07

HLX10

placebo

chemotherapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma by AJCC V8 Stage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Voluntarily participate in the clinical study; fully understand, be informed about the study, and have signed the informed consent form (ICF); be willing to follow and be able to complete all trial procedures.
Males or females aged ≥ 18 years at the time of signing the ICF.
Histologically or cytologically proven recurrent or metastastic NPC.
At least one measurable target lesion is assessed by the IRRC according to the RECIST v1.1 within 4 weeks prior to randomization.
An ECOG performance status score of 0-1 within 7 days prior to the first dose of the investigational product.
An expected survival period ≥ 12 weeks.

Exclusion Criteria:

Other active malignancies within 3 years prior to the first dose of investigational product. Localized tumors that have been cured such as superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast cancer in situ are acceptable.
Patients who are going to receive or have received an organ or bone marrow transplant.
With uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (monthly or more frequently).
With cerebrovascular accident, myocardial infarction, unstable angina, poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia formula) within half a year.
Class III to IV cardiac insufficiency according to New York Heart Association (NYHA) classification (Appendix 5) or an LVEF (left ventricular ejection fraction) < 50% by cardiac color Doppler.
Inadequately controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg).
With human immunodeficiency virus (HIV) infection.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

HLX07+HLX10+chemotherapy

Placebo+HLX10+chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

ORR

Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)

Secondary Outcome Measures

PFS

Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC and INV according to the RECIST v1.1 criteria.

Full Information

NCT ID

NCT05513573

First Posted

August 18, 2022

Last Updated

August 7, 2023

Sponsor

Shanghai Henlius Biotech

1. Study Identification

Unique Protocol Identification Number

NCT05513573

Brief Title

Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC

Official Title

A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 14, 2022 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Henlius Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma by AJCC V8 Stage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HLX07+HLX10+chemotherapy

Arm Type

Experimental

Arm Title

Placebo+HLX10+chemotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

HLX07

Intervention Description

1500 mg, D1，Q3W

Intervention Type

Drug

Intervention Name(s)

HLX10

Intervention Description

300 mg, D1, up to 2 years,Q3W

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

1500 mg, D1，Q3W

Intervention Type

Drug

Intervention Name(s)

chemotherapy

Intervention Description

gemcitabine 1000 mg/m2, D1,D8; cisplatin 80 mg/m2,D1；Q3W, up to 6 cycles

Primary Outcome Measure Information:

Title

ORR

Description

Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)

Time Frame

up to 24 weeks

Secondary Outcome Measure Information:

Title

PFS

Description

Time Frame

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Voluntarily participate in the clinical study; fully understand, be informed about the study, and have signed the informed consent form (ICF); be willing to follow and be able to complete all trial procedures. Males or females aged ≥ 18 years at the time of signing the ICF. Histologically or cytologically proven recurrent or metastastic NPC. At least one measurable target lesion is assessed by the IRRC according to the RECIST v1.1 within 4 weeks prior to randomization. An ECOG performance status score of 0-1 within 7 days prior to the first dose of the investigational product. An expected survival period ≥ 12 weeks. Exclusion Criteria: Other active malignancies within 3 years prior to the first dose of investigational product. Localized tumors that have been cured such as superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast cancer in situ are acceptable. Patients who are going to receive or have received an organ or bone marrow transplant. With uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (monthly or more frequently). With cerebrovascular accident, myocardial infarction, unstable angina, poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia formula) within half a year. Class III to IV cardiac insufficiency according to New York Heart Association (NYHA) classification (Appendix 5) or an LVEF (left ventricular ejection fraction) < 50% by cardiac color Doppler. Inadequately controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg). With human immunodeficiency virus (HIV) infection.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Zhang

zhangli@sysucc.org.cn

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guanzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Zhang

12. IPD Sharing Statement

Plan to Share IPD

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