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Trial Title:
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
NCT ID:
NCT05513573
Condition:
Nasopharyngeal Carcinoma by AJCC V8 Stage
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
HLX07
Description:
1500 mg, D1,Q3W
Arm group label:
HLX07+HLX10+chemotherapy
Intervention type:
Drug
Intervention name:
HLX10
Description:
300 mg, D1, up to 2 years,Q3W
Arm group label:
HLX07+HLX10+chemotherapy
Arm group label:
Placebo+HLX10+chemotherapy
Intervention type:
Drug
Intervention name:
placebo
Description:
1500 mg, D1,Q3W
Arm group label:
Placebo+HLX10+chemotherapy
Intervention type:
Drug
Intervention name:
chemotherapy
Description:
gemcitabine 1000 mg/m2, D1,D8; cisplatin 80 mg/m2,D1;Q3W, up to 6 cycles
Arm group label:
HLX07+HLX10+chemotherapy
Arm group label:
Placebo+HLX10+chemotherapy
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)
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guanzhou
Zip:
510060
Country:
China
Start date:
December 14, 2022
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Shanghai Henlius Biotech
Agency class:
Industry
Source:
Shanghai Henlius Biotech
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05513573