Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT04297995
Status:
UNKNOWN
Last Update Posted:
2023-08-08
First Post:
2020-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors
Sponsor:
Shanghai Henlius Biotech
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Part 1:
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.
Part 2:
This is 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. Approximately 75 first-line R/M HNSCC subjects are planned to be recruited. The sample size calculation is not based on the statistical hypothesis.
Eligible subjects after screening will be randomly assigned to the treatment group (group A) or the control group (group B) in a ratio of 2:1, with PD-L1 CPS (≥ 20 and \< 20) as the stratification factor at randomization (Figure 1):
Group A: approximately 50 subjects, HLX10 in combination with HLX07 and chemotherapy (cisplatin in combination with 5-FU).
Group B: approximately 25 subjects, HLX10 in combination with placebo and chemotherapy (cisplatin in combination with 5-FU).
Cisplatin may be replaced with carboplatin when the subject is judged intolerant to cisplatin by the INV.
The study will be unblinded overall for ORR analysis approximately 3 months after the first dose of the last subject.
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.
Part 2:
This is 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. Approximately 75 first-line R/M HNSCC subjects are planned to be recruited. The sample size calculation is not based on the statistical hypothesis.
Eligible subjects after screening will be randomly assigned to the treatment group (group A) or the control group (group B) in a ratio of 2:1, with PD-L1 CPS (≥ 20 and \< 20) as the stratification factor at randomization (Figure 1):
Group A: approximately 50 subjects, HLX10 in combination with HLX07 and chemotherapy (cisplatin in combination with 5-FU).
Group B: approximately 25 subjects, HLX10 in combination with placebo and chemotherapy (cisplatin in combination with 5-FU).
Cisplatin may be replaced with carboplatin when the subject is judged intolerant to cisplatin by the INV.
The study will be unblinded overall for ORR analysis approximately 3 months after the first dose of the last subject.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: