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SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC

ConditionHead and Neck Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

This is a Phase II study of anti-nectin-4 ADC combined with the EGFR monoclonal antibody and the PD-1 monoclonal antibody in participants with advanced head and neck squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older, regardless of gender.

Able to understand and voluntarily sign a written informed consent form (ICF).

Confirmed recurrent or metastatic HNSCC that is not curable with local treatments. Primary tumor must be located in the oral cavity, oropharynx, hypopharynx, or larynx.

Able to provide well-preserved or fresh tumor tissue.

Disqualifiers

Primary tumor located in the nasopharynx, nasal cavity, paranasal sinuses, salivary glands, thyroid or parathyroid glands, skin, or squamous cell carcinoma with an unknown primary site.

Presence of leptomeningeal metastasis, spinal cord compression, symptomatic or progressive brain metastases.

(Only for Stage 2 in Part 2) Prior systemic anti-tumor therapy for recurrent or metastatic HNSCC.

Known allergy to any component of SYS6002, JMT101, or Enlonstobart injection.

Trial design

Design model

Factorial

Treatments tested in this trial

  • JMT101

    Drug

    JMT101 Q2W or Q3W, intravenous injection

  • SYS6002

    Drug

    SYS6002 Q2W or Q3W, intravenous injection

  • SG001

    Drug

    SG001 Q2W or Q3W, intravenous injection

Treatment groups

430 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: SYS6002 monotherapy (Q2W)Experimental treatment 1 intervention
Group B: SYS6002 monotherapy (Q3W)Experimental treatment 1 intervention
Group C: JMT101 monotherapyExperimental treatment 1 intervention
Group D: SYS6002 combinational therapy (Q2W)Experimental treatment 3 interventions
Group E: SYS6002 combinational therapy (Q3W)Experimental treatment 3 interventions
Group F: Factorial GroupExperimental treatment 2 interventions
Group G: Experimental Group 1Experimental treatment 3 interventions
Group H: Experimental Group 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Dose-limiting Toxicities (DLTs)

Time frame
Up to 28 days
2

Incidence of Adverse Events (AEs)

Time frame
Up to approximately 2 years
3

Maximum Tolerated Dose (MTD)

Time frame
Up to approximately 2 years
4

Objective Response Rate (ORR)

Time frame
Up to approximately 2 years

Secondary outcomes

1

Disease Control Rate (DCR)

Time frame
Up to approximately 2 years
2

Duration of Response (DOR)

Time frame
Up to approximately 2 years
3

Progression-free Survival (PFS)

Time frame
Up to approximately 2 years
4

Overall Survival (OS)

Time frame
Up to approximately 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

CSPC Megalith Biopharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: