SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCC

NCT07758621 | Not Yet Recruiting Phase 3

• 1 other identifier: SYS6010-023
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 2 years

• 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.

  Up to approximately 2 years

Secondary Outcomes (8)

• Objective Response Rate (ORR) as assessed by investigators

  Up to approximately 2 years

• Duration of Response (DOR)

  Up to approximately 2 years

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Progression Free Survival (PFS)

  Up to approximately 2 years

• Incidence of adverse events assessed by CTCAE v6.0.

  Up to approximately 2 years

Study Arms (2)

SYS6010

EXPERIMENTAL

SYS6010 monotherapy

Drug: SYS6010

Investigator's choice of monotherapy

ACTIVE COMPARATOR

Investigator's choice of one of treatment (docetaxel,methotrexate, paclitaxel or cetuximab)

Drug: Investigator's Choice of monotherapy

Interventions

SYS6010 DRUG

SYS6010 by intravenous (IV)

SYS6010

Investigator's Choice of monotherapy DRUG

Investigator'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）.

Investigator's choice of monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Life expectancy of ≥ 3 months;
• Adequate major organ function (hematology, renal, liver, and coagulation) as determined by laboratory tests performed within 7 days prior to randomization;
• Sexually active fertile participants must agree to use methods of contraception during the study and at least 7 months after termination of study therapy and have a negative serum pregnancy test within 7 days prior to randomization;
• Willing to participate in the study, understand the study procedures, and sign a written informed consent form.

You may not qualify if:

• 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);
• Prior treatment with TOP1(including ADCs);
• Prior EGFR mAb therapy within 4 months prior to treatment;
• Adverse events from prior antitumor therapy not recovered to Grade ≤ 1 per NCI-CTCAE v6.0；
• Use of any of the medications or treatments within the specified washout period (prior to randomization )
• History of serious cardiovascular or cerebrovascular conditions within 6 months prior to randomization, including but not limited to: Severe arrhythmias (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, QTcF \> 470 ms) (Fridericia formula: QTcF = QT/RR0.33, RR = 60/heart rate). Myocardial infarction, unstable angina, aortic dissection, angioplasty, or coronary artery bypass surgery. NYHA class II or higher heart failure with LVEF \< 50%.Stroke or other grade ≥ 3 cardiovascular/cerebrovascular events. pulmonary embolism;
• Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels; and the investigator assessed that there was no risk of bleeding.
• Patients who have a history of ILD/non-infectious pneumonitis treated with corticosteroids in the past, currently have ILD/non-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD/non-infectious pneumonitis,
• Severe infection within 4 weeks prior to randomization, such as bacteremia requiring hospitalization, severe pneumonia, or active pulmonary tuberculosis;active systemic infections requiring antibiotics within 2 weeks prior to randomization;
• Previous permanent discontinuation of EGFR-targeted therapy due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication;
• History of ulcerative colitis or Crohn's disease;
• Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to randomization;

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Kunyu Yang

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible Participants in this trial will be randomized in a 1:1 ratio to one of two treatment arms

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 11, 2026

Record last verified: 2026-08