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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-14

Study Completion Date

2026-09-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Nasopharyngeal Carcinoma by AJCC V8 Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HLX07+HLX10+chemotherapy

Group Type EXPERIMENTAL

HLX07

Intervention Type DRUG

1500 mg, D1，Q3W

HLX10

Intervention Type DRUG

300 mg, D1, up to 2 years,Q3W

chemotherapy

Intervention Type DRUG

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

Placebo+HLX10+chemotherapy

Group Type EXPERIMENTAL

HLX10

Intervention Type DRUG

300 mg, D1, up to 2 years,Q3W

placebo

Intervention Type DRUG

1500 mg, D1，Q3W

chemotherapy

Intervention Type DRUG

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

Interventions

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HLX07

1500 mg, D1，Q3W

Intervention Type DRUG

HLX10

300 mg, D1, up to 2 years,Q3W

Intervention Type DRUG

placebo

1500 mg, D1，Q3W

Intervention Type DRUG

chemotherapy

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Males or females aged ≥ 18 years at the time of signing the ICF.
3. Histologically or cytologically proven recurrent or metastastic NPC.
4. At least one measurable target lesion is assessed by the IRRC according to the RECIST v1.1 within 4 weeks prior to randomization.
5. An ECOG performance status score of 0-1 within 7 days prior to the first dose of the investigational product.
6. An expected survival period ≥ 12 weeks.

Exclusion Criteria

1. 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.
2. Patients who are going to receive or have received an organ or bone marrow transplant.
3. With uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (monthly or more frequently).
4. 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.
5. 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.
6. Inadequately controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg).
7. With human immunodeficiency virus (HIV) infection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No