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

NCT05513573 | Active Not Recruiting Phase 2

• 1 other identifier: HLX07-NPC201
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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)

Conditions

Nasopharyngeal Carcinoma by AJCC V8 Stage

Outcome Measures

Primary Outcomes (1)

• ORR

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

  up to 24 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

HLX07+HLX10+chemotherapy

EXPERIMENTAL

Drug: HLX07; Drug: HLX10; Drug: chemotherapy

Placebo+HLX10+chemotherapy

EXPERIMENTAL

Drug: HLX10; Drug: placebo; Drug: chemotherapy

Interventions

HLX07 DRUG

1500 mg, D1，Q3W

HLX07+HLX10+chemotherapy

HLX10 DRUG

300 mg, D1, up to 2 years,Q3W

HLX07+HLX10+chemotherapy; Placebo+HLX10+chemotherapy

placebo DRUG

1500 mg, D1，Q3W

Placebo+HLX10+chemotherapy

chemotherapy DRUG

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

HLX07+HLX10+chemotherapy; Placebo+HLX10+chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

HLX07; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 24, 2022
• Study Start: December 14, 2022
• Primary Completion: September 30, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)