Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors

Summary

Part1:

A mutilpe-center, open-label, Phase II clinical trial to evaluate the efficacy and the safety of HLX10 in combination with HLX07 in patients with advanced advanced head and neck tumors.

Part2:

A randomized, double-blind, multi-center, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 in combination with HLX07 and chemotherapy versus HLX10 in combination with placebo and chemotherapy in the first-line treatment of R/M HNSCC.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

HLX10

Part 1: HLX10 3 mg/kg biweekly. Part 2: HLX10 300 mg every three weeks.

DRUG

HLX07

Part 1: HLX07 600 mg weekly (stage 1L). Part 1: HLX07 800 mg weekly (stage 1H). Part 2: HLX07 1000 mg every three weeks.

DRUG

HLX07 placebo

HLX07 placebo 1000 mg every three weeks

DRUG

Cisplatin/Carboplatin

Cisplatin 100 mg/m2 every three weeks. Cisplatin will be switched to carboplatin in case of intolerance to cisplatin. Up to 6 cycles.

DRUG

5-FU

5-FU 1000 mg/m2/day, 1-4 days, every three weeks. Up to 6 cycles.

Sponsors & Collaborators

• Shanghai Henlius Biotech

  lead INDUSTRY

Principal Investigators

• Ye Guo, PhD · Shanghai East Hospital

• Guochun Cao · Jiangsu Cancer Institute & Hospital

• Meiyu Fang · Cancer Hospital of The University of Chinese Academy of Sciences

• Guangyuan Hu · Tongji Hospital

• Xiaohui He · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

• Yan Sun · Peking University Cancer Hospital & Institute

• Wei Wang · Hunan Cancer Hospital

• Shubin Wang · Peking University Shenzhen Hospital

• Qingyuan Zhang · The Second Affiliated Hospital of Harbin Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-29

Primary Completion

2024-05-30

Completion

2025-06-30

Countries

• China

Study Locations