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

NCT04297995 | Unknown Phase 2

• 1 other identifier: HLX10HLX07-001
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Part1: Efficacy-ORR

  Objective Response Rate (ORR)

  at 16 weeks after first dose

• Part1: Safety-adverse event profile

  The proportion of patients suffered from drug related toxicities.

  up to one year

• Part2: Efficacy-ORR (IRRC)

  Objective Response Rate (ORR) assessed by the Independent Radiological Review Committee (IRRC) per RECIST v1.1.

  at 3 months after first dose

Secondary Outcomes (10)

• Efficacy-Best ORR

  up to one year

• Efficacy-PFS

  up to one year

• Efficacy-OS

  up to one year

• The number of presence patients that develop of anti-durg antibody (immunogenicity).

  up to one year

• maximum concentration (Cmax)

  up to one year

Study Arms (4)

Part 1: HLX10 Plus HLX07 (stage 1L)

EXPERIMENTAL

3 mg/kg of HLX10 every two weeks infusion combined with 600 mg HLX07 weekly

Drug: HLX10; Drug: HLX07

Part 1: HLX10 Plus HLX07 (Stage 1H)

EXPERIMENTAL

3 mg/kg of HLX10 every two weeks infusion combined with 800 mg HLX07 weekly

Drug: HLX10; Drug: HLX07

Part 2: HLX10 Plus HLX07 Plus Chemotherapy

EXPERIMENTAL

HLX10 (300 mg) Plus HLX07 (1000 mg) Plus Cisplatin (100 mg/m2) Plus 5-FU (1000 mg/m2/day, 1-4 days). Cisplatin will be switched to carboplatin in case of intolerance to cisplatin. Up to 6 cycles of chemotherapy.

Drug: HLX10; Drug: HLX07; Drug: Cisplatin/Carboplatin; Drug: 5-FU

Part 2: HLX10 Plus HLX07 Placebo Plus Chemotherapy

PLACEBO COMPARATOR

HLX10 (300 mg) Plus HLX07 Placebo (1000 mg) Plus Cisplatin (100 mg/m2) Plus 5-FU (1000 mg/m2/day, 1-4 days). Cisplatin will be switched to carboplatin in case of intolerance to cisplatin. Up to 6 cycles of chemotherapy.

Drug: HLX10; Drug: HLX07 placebo; Drug: Cisplatin/Carboplatin; Drug: 5-FU

Interventions

HLX10 DRUG

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

Part 1: HLX10 Plus HLX07 (Stage 1H); Part 1: HLX10 Plus HLX07 (stage 1L); Part 2: HLX10 Plus HLX07 Placebo Plus Chemotherapy; Part 2: HLX10 Plus HLX07 Plus Chemotherapy

HLX07 DRUG

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

Part 1: HLX10 Plus HLX07 (Stage 1H); Part 1: HLX10 Plus HLX07 (stage 1L); Part 2: HLX10 Plus HLX07 Plus Chemotherapy

HLX07 placebo DRUG

HLX07 placebo 1000 mg every three weeks

Part 2: HLX10 Plus HLX07 Placebo Plus Chemotherapy

Cisplatin/Carboplatin DRUG

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

Part 2: HLX10 Plus HLX07 Placebo Plus Chemotherapy; Part 2: HLX10 Plus HLX07 Plus Chemotherapy

5-FU DRUG

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

Part 2: HLX10 Plus HLX07 Placebo Plus Chemotherapy; Part 2: HLX10 Plus HLX07 Plus Chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients must be 18 years of age or older or per local regulation AND younger than 80 years old age.
• Patients with histologically-proven recurrent (not amenable to locally curative treatment options) or metastatic, squamous cell carcinoma of the head and neck with previously failed platinum-based chemotherapy and PD-L1 expression (combined positive score ≥ 1) as determined by immunohistochemistry (IHC) stain. (Patient must be able to provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy; fine needle aspirate is not sufficient.: A newly obtained biopsy; within 90 days prior to start of study treatment; is preferred but an archival sample is acceptable.)
• Lesion must be measurable based on RECIST, version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at the time of study entry.
• Able to provide informed consent.
• A life expectancy longer than three months.
• Adequate hematologic functions, as defined by: absolute neutrophil counts (ANC) ≥ 1500/mm3; a hemoglobin (Hb) level ≥ 9 gm/dL; a platelet count ≥ 100,000/mm3.
• Adequate hepatic function defined by: a total bilirubin level ≤ 1.5x of upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x of ULN or ≤ 5x of ULN in known hepatic metastases.
• Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute calculated using Cockcroft-Gault formula. In patient with extreme body weight (body mass index \[BMI\] \< 18.5 or \> 30), estimated glomerular filtration rate (GFR) ≥ 50mL/min calculated using Modification of Diet in Renal Disease (MDRD) formula is acceptable.
• Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50% measured by multigated acquisition (MUGA) scan or cardiac ultrasound.
• Use of effective contraceptive measures if procreative potential exists .
• At least 28 days from prior major surgery, prior cytotoxic chemotherapy, or prior therapy with investigational agents (or medical device) and curative radiotherapy or palliative radiotherapy to target lesion before the first infusion of investigational product.
• Able to follow the procedures as required by the study protocol and must agree to provide tumor tissue for programmed cell death 1 (PD-L1) expression analyses, EGFR mutation status, and biomarker assessment.

You may not qualify if:

• Patients who still have persistent ≥ grade 2 toxicities from prior therapies.
• Patients with primary nasopharynx cancers.
• Squamous cell carcinoma of unknown primary in cervical lymph node.
• Concurrent unstable or uncontrolled medical conditions. Either of the followings:
• Active systemic infections currently under treatment with antimicrobial agents;
• Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg), or poor compliance with anti-hypertensive agents;
• Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (class III or IV of New York Heart Association \[NYHA\]) or acute myocardial infarction within 12 months;
• Uncontrolled diabetes or poor compliance with hypoglycemic agents;
• The presence of chronically unhealed wound or ulcers;
• Other chronic diseases, which, in the opinion of the investigator, could compromise safety of the patient or the integrity of study.
• Newly-diagnosed or symptomatic brain metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, must be clinically stable, and must not taking steroids for brain edema for at least 14 days to be allowed in the study). Anticonvulsants are allowed.
• Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 3 years can participate).
• Pregnancy (confirmed by serum beta human chorionic gonadotropin \[ßHCG\]) or breast-feeding.
• Known history of human immunodeficiency virus infection (HIV).
• Patient who has an active or a documented history of autoimmune disease.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Shanghai Henlius Biotech Inc.

Shanghai, Shanghai Municipality, 200233, China

Location

Related Publications (2)

• Y. Guo, W. Wang, G. Cao, et al. A phase 2 study of serplulimab plus HLX07 in patients with advanced head and neck tumours. Abstract Book. ICHNO-ECHNO 2022: 590

  RESULT

• Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.

  PMID: 40932107 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

HLX07; Cisplatin; Carboplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ye Guo, PhD

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

• Guochun Cao

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

• Meiyu Fang

  Cancer Hospital of The University of Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Guangyuan Hu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Xiaohui He

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Yan Sun

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Wei Wang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Shubin Wang

  Peking University Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

• Qingyuan Zhang

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part 1: open label. Part 2: Matters related to the blinding of study treatment will be carried out by the statistics department. The subjects, the INV, the sponsor, and designees are not aware of the randomized allocation. This study will be unblinded overall approximately 3 months after the first administration in the last subject. Unblinding is allowed unless there is an emergency medical condition (emergency treatment is only possible when being informed of the randomized medication) or unblinding is requested by the regulatory authorities. Otherwise, the study should remain blinded. Only when all data have been input into the database, all data queries have been resolved, and subjects have been allocated into analysis sets, can the randomization codes be unblinded.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 6, 2020
• Study Start: July 29, 2020
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)