Clinical Trials/NCT05513573

NCT05513573

Active, Not Recruiting

Phase 2

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)

Shanghai Henlius Biotech1 site in 1 country75 target enrollmentDecember 14, 2022

ConditionsNasopharyngeal Carcinoma by AJCC V8 Stage

InterventionsHLX10 HLX07 chemotherapy placebo

DrugsHLX07 HLX10 placebo chemotherapy

Overview

Phase: Phase 2
Intervention: HLX10
Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage
Sponsor: Shanghai Henlius Biotech
Enrollment: 75
Locations: 1
Primary Endpoint: ORR
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

December 14, 2022

End Date

September 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Henlius Biotech

Responsible Party

Sponsor

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.

Arms & Interventions

Placebo+HLX10+chemotherapy

Intervention: HLX10

HLX07+HLX10+chemotherapy

Intervention: HLX07

HLX07+HLX10+chemotherapy

Intervention: HLX10

HLX07+HLX10+chemotherapy

Intervention: chemotherapy

Placebo+HLX10+chemotherapy

Intervention: placebo

Placebo+HLX10+chemotherapy

Intervention: chemotherapy

Outcomes

Primary Outcomes

ORR

Time Frame: up to 24 weeks

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

Secondary Outcomes

PFS(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)