Health TrialsbyHealthPanel

SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma

ConditionHead and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

This study is a n open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart in the recurrent or metastatic head and neck squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 (inclusive) years old, male or females;

Participants with histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma who are not suitable for radical surgery or concurrent chemoradiotherapy.

For SYS6010 combined with Enlonstobart group: Participants who have not previously received systemic anti-tumor treatment. If participants have received neoadjuvant or adjuvant therapy (or combination targeted therapy), they are eligible if disease progression occurs at least 6 months after the last administration.

For Enlonstobart group: Participants who have not previously received immunotherapy are included. For participants who have not previously undergone systemic antitumor treatment, baseline PD-L1 positivity (CPS≥1) must be confirmed by the central laboratory; for participants who have previously received systemic antitumor treatment, there is no restriction on baseline PD-L1 expression.

Disqualifiers

The primary sites include the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin; Histologically or cytologically confirmed combined neuroendocrine carcinoma, mesenchymal tumors or carcinosarcoma.

Patients with meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with supratentorial and/or cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to the first dose of the study intervention (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;

Patients with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;

Patients who are known to be allergic to any component of SYS6010, Enlonstobart or to humanized monoclonal antibody products;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYS6010 injection

    Drug

    SYS6010will be administrated on a 14-day cycle

  • Enlonstobart injection

    Drug

    Enlonstobart is a recombinant human anti-PD-1 monoclonal antibody

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: SYS6010 combined with enlonstobart groupExperimental treatment 2 interventions
Group B: Enlonstobart groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate(ORR) assessed by investigator

Time frame
1 year
2

Incidences of Adverse Events and Serious Adverse Events

Time frame
1 year

Secondary outcomes

1

Progression Free Survival(PFS) and Overall survival(OS)

Time frame
1.5 years
2

Immunogenicity of SYS6010 and Enlonstobart

Time frame
1 year
3

The plasma concentration of SYS6010 and Enlonstobart

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC Megalith Biopharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now