SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCC
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy, safety of SYS6010 compared with monotherapy in participants with HNSCC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participantss aged 18-75 years (inclusive);
Patients with pathologically confirmed head and neck squamous cell carcinoma (HNSCC);.
Participants have failed of platinum-based chemotherapy and PD-(L)1 inhibitors; for participants who received platinum-based chemotherapy and PD-(L)1 inhibitors in the adjuvant/neoadjuvant setting, disease recurrence or progression must have occurred within 6 months after completion of that therapy; radiographically confirmed disease progression during or after the most recent treatment regimen;
Participants must have measurable disease according to RECIST (version 1.1);
Disqualifiers
Pathologically confirmed patients with adenocarcinoma or sarcomatoid carcinoma etc.;
Active central nervous system metastases or leptomeningeal metastasis;
History of another malignancy within 3 years prior to randomization
Allergy to any component of SYS6010 or to humanized monoclonal antibodies，or to the control drugs (docetaxel, methotrexate, paclitaxel, cetuximab);
Trial design
Design model
Parallel
Treatments tested in this trial
SYS6010
DrugSYS6010 by intravenous (IV)
Investigator's Choice of monotherapy
DrugInvestigator's choice of monotherapy means the therapy chosen by investigators to treat HNSCC including docetaxel (35 mg/m\^2 by IV on Day 1、8、15, every 28 days),methotrexate（40 mg/m\^2 by IV on Day 1、8、15, every 21 days）, paclitaxel (80 mg/m\^2 by IV on Day 1、8、15, every 28 days) or cetuximab（400 mg/m\^2 by IV on C1D1, followed by 250 mg/m\^2 weekly）.
Treatment groups
340 Participants
are divided into 2 treatment groupsGroup A: SYS6010Experimental treatment 1 intervention
Group B: Investigator's choice of monotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR) as assessed by IRC per RECIST v.1.1.
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Time frame
Up to approximately 2 years2
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Objective Response Rate (ORR) as assessed by investigators
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1
Time frame
Up to approximately 2 years2
Duration of Response (DOR)
DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.
Time frame
Up to approximately 2 years3
Disease Control Rate (DCR)
The percentage of participants who experience a best response of CR, PR or stable disease (SD).
Time frame
Up to approximately 2 years4
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Time frame
Up to approximately 2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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