SYS6002 Plus JMT101 and Enlonstobart Injection as First-Line Treatment for HNSCC

CSPC Megalith Biopharmaceutical Co.,Ltd.

Status and phase: Not yet enrolling; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: SYS6002; Drug: SYSA1802; Drug: JMT101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06989671

SYS6002-003

Details and patient eligibility

About

This is a Phase II study of anti-nectin-4 ADC combined with the EGFR monoclonal antibody and the PD-1 monoclonal antibody in patients with advanced head and neck squamous cell carcinoma who have not received previous systemic treatment

Full description

This trial is divided into two parts. Part 1 (combination therapy group) consists of Stage 1 (dose escalation) and Stage 2 (proof of conception study), in which Stage 2 adopts a randomized, controlled, open-label, multicenter design; Part 2 (monotherapy group) is SYS6002 monotherapy, divided into two cohorts with different dose groups. After completing the dose escalation of Part 1 (combination therapy group), and combining with the efficacy and safety data of SYS6002 monotherapy in Part 2 of this study and other clinical studies in participants with ≥2L HNSCC, the decision to enter Stage 2 in Part I (combination therapy group) will be made by discussion between the sponsor and the investigator.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, at least one measurable lesion confirmed by CT or MRI.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival time of ≥ 3 months.
• Normal major organ function within 7 days prior to treatment.

Exclusion criteria

• 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 Part 1) Prior systemic anti-tumor therapy for recurrent or metastatic HNSCC.
• Known allergy to any component of SYS6002, JMT101, or Enlonstobart injection.
• Participants who have previously received MMAE toxin ADC treatment (only for Part 2 participants).
• Adverse events related to prior anti-tumor treatment that have not resolved to ≤ Grade 1 according to NCI-CTCAE v5.0 (except for toxicities deemed low-risk by the investigator, such as Grade 2 alopecia).
• Washout period not met for anti-tumor medications or treatments.
• Any serious and/or uncontrolled comorbid conditions that may interfere with the participant's ability to participate in the study
• Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test within 7 days before enrollment. Breastfeeding women may participate if they stop breastfeeding, but they cannot resume breastfeeding during the treatment and after the study ends.
• Any male or female participants of childbearing potential who refuse to use highly effective contraception during the study and for 6 months after the last dose of study drug.
• Unwilling or unable to comply with the study procedures and requirements, or deemed unsuitable for participation by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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250 participants in 7 patient groups

Dose escalation arm

Experimental group

Treatment:

Drug: JMT101

Drug: SYSA1802

Drug: SYS6002

Experimental Group 1

Experimental group

Treatment:

Drug: JMT101

Drug: SYSA1802

Drug: SYS6002

Experimental Group 2

Experimental group

Treatment:

Drug: JMT101

Drug: SYSA1802

Drug: SYS6002

Factorial Group 1

Experimental group

Treatment:

Drug: SYSA1802

Drug: SYS6002

Factorial Group 2

Experimental group

Treatment:

Drug: SYS6002

SYS6002 single agent 1

Experimental group

Treatment:

Drug: SYS6002

SYS6002 single agent 2

Experimental group

Treatment:

Drug: SYS6002