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

Henlius Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage

Treatments: Drug: chemotherapy; Drug: HLX07; Drug: HLX10; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05513573

HLX07-NPC201

Details and patient eligibility

About

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)

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups

HLX07+HLX10+chemotherapy

Experimental group

Treatment:

Drug: HLX10

Drug: HLX07

Drug: chemotherapy

Placebo+HLX10+chemotherapy

Experimental group

Treatment:

Drug: placebo

Drug: HLX10

Drug: chemotherapy