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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297995
Recruitment Status : Active, not recruiting
First Posted : March 6, 2020
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Experimental: Stage 1L: HLX10 Plus HLX07 Drug: Experimental: Stage 1H: HLX10 Plus HLX07 Phase 2

Detailed Description:

This is an open label study. Sample size recommendations for this phase II study are determined according to Simon's two-stage Optimal design.

In the first stage, 13 patients will be accrued. The patients will receive 3 mg/kg of HLX10 every two weeks infusion combined with 600 mg HLX07 weekly (stage 1L). These patients will be assessed for treatment response after 8 weeks of first infusion of study drugs. If there are 3 or fewer responsive patients in these 13 patients, additional 13 patients will be accrued. These additional 13 patients will receive 3 mg/kg of HLX10 every two weeks infusion combined with 800 mg HLX07 weekly (Stage 1H). If 3 or fewer responses after eight weeks treatment noted in these 13 patients in stage 1H, the trial will be stopped.

If 4 or more patients are responsive to therapy in stage 1, the trial will be continued to stage 2, 30 additional patients will be accrued to reach a total of 43 patients. These additional 30 patients will receive the same dose of regimen as the prior patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluate the Efficacy and Safety of HLX10, PD-1 mAb, in Combination With HLX07, EGFR mAb, in Patients With Advanced Head And Neck Tumors
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HLX10 Plus HLX07 (stage 1L)
3 mg/kg of HLX10 every two weeks infusion combined with 600 mg HLX07 weekly
Drug: Experimental: Stage 1L: HLX10 Plus HLX07
3 mg/kg of HLX10 every two weeks infusion combined with 600 mg HLX07 weekly

Experimental: HLX10 Plus HLX07 (Stage 1H)
3 mg/kg of HLX10 every two weeks infusion combined with 800 mg HLX07 weekly
Drug: Experimental: Stage 1H: HLX10 Plus HLX07
3 mg/kg of HLX10 every two weeks infusion combined with 800 mg HLX07 weekly




Primary Outcome Measures :
  1. Efficacy-ORR [ Time Frame: at 16 weeks after first dose ]
    Objective Response Rate (ORR)

  2. Safety-adverse event profile [ Time Frame: up to one year ]
    The proportion of patients suffered from drug related toxicities.


Secondary Outcome Measures :
  1. Efficacy-Best ORR [ Time Frame: up to one year ]
    Best response rate (Best ORR)

  2. Efficacy-PFS [ Time Frame: up to one year ]
    Progression-free survival (PFS)

  3. Efficacy-OS [ Time Frame: up to one year ]
    Overall survival (OS)

  4. The number of presence patients that develop of anti-durg antibody (immunogenicity). [ Time Frame: up to one year ]
  5. maximum concentration (Cmax) [ Time Frame: up to one year ]
  6. trough concentration (Ctrough) [ Time Frame: up to one year ]
  7. half-life (T1/2) [ Time Frame: up to one year ]
  8. clearance rate (CL) [ Time Frame: up to one year ]
  9. volume of distribution (Vss) [ Time Frame: up to one year ]
  10. area under concentration (AUC0-tau) [ Time Frame: up to one year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Eligible patients must be 18 years of age or older or per local regulation AND younger than 80 years old age.
  2. 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.)
  3. Lesion must be measurable based on RECIST, version 1.1.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at the time of study entry.
  5. Able to provide informed consent.
  6. A life expectancy longer than three months.
  7. 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.
  8. 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.
  9. 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.
  10. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50% measured by multigated acquisition (MUGA) scan or cardiac ultrasound.
  11. Use of effective contraceptive measures if procreative potential exists .
  12. 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.
  13. 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.

Exclusion Criteria:

  1. Patients who still have persistent ≥ grade 2 toxicities from prior therapies.
  2. Patients with primary nasopharynx cancers.
  3. Squamous cell carcinoma of unknown primary in cervical lymph node.
  4. 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.
  5. 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.
  6. 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).
  7. Pregnancy (confirmed by serum beta human chorionic gonadotropin [ßHCG]) or breast-feeding.
  8. Known history of human immunodeficiency virus infection (HIV).
  9. Patient who has an active or a documented history of autoimmune disease.
  10. Patient who has active hepatitis B (HBV DNA titer > 100 IU/mL or > 500 copies/mL) or hepatitis C (defined as anti-HCV antibody reactive and/ or detectable HCV RNA > 15 IU/L).
  11. Patient who has a history of interstitial lung disease.
  12. Have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of autoimmune disease.
  13. Patients who have failed systemic anti-EGFR monoclonal antibody therapies (who have PD or PFS less than 3 months during anti EGFR treatment) or have been received more than 3 lines of systemic chemotherapy regimens.
  14. Patients who previously have severe allergic reaction to anti-EGFR monoclonal antibody (CTCAE grade ≥3).
  15. Patients who have previously received immune check point therapy, including but not limit to anti-PD1 and anti-PDL1.
  16. The patient is the investigator, sub-investigator or any one directly involved in the conduct of the study.
  17. Patient has a history or current evidence of any condition or disease that could confound the results of the study, or study or is not the best interest of the patient to participate, in the opinion of Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297995


Locations
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China, Shanghai
Shanghai Henlius Biotech Inc.
Shanghai, Shanghai, China, 200233
Sponsors and Collaborators
Shanghai Henlius Biotech
Investigators
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Principal Investigator: 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 Harbin Medical University
Additional Information:
Publications of Results:
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

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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT04297995    
Other Study ID Numbers: HLX10HLX07-001
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site