SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC

NCT06989671 | Not Yet Recruiting Phase 2

• 1 other identifier: SYS6002-003
• Study Type: interventional
• Target: 430
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (4)

• Dose-limiting Toxicities (DLTs)

  Up to 28 days

• Incidence of Adverse Events (AEs)

  Up to approximately 2 years

• Maximum Tolerated Dose (MTD)

  Up to approximately 2 years

• Objective Response Rate (ORR)

  Up to approximately 2 years

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Duration of Response (DOR)

  Up to approximately 2 years

• Progression-free Survival (PFS)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 3 years

Study Arms (8)

SYS6002 monotherapy (Q2W)

EXPERIMENTAL

Drug: SYS6002

SYS6002 monotherapy (Q3W)

EXPERIMENTAL

Drug: SYS6002

JMT101 monotherapy

EXPERIMENTAL

Drug: JMT101

SYS6002 combinational therapy (Q2W)

EXPERIMENTAL

Drug: JMT101; Drug: SYS6002; Drug: SG001

SYS6002 combinational therapy (Q3W)

EXPERIMENTAL

Drug: JMT101; Drug: SYS6002; Drug: SG001

Factorial Group

EXPERIMENTAL

Drug: SYS6002; Drug: SG001

Experimental Group 1

EXPERIMENTAL

Drug: JMT101; Drug: SYS6002; Drug: SG001

Experimental Group 2

EXPERIMENTAL

Drug: JMT101; Drug: SYS6002; Drug: SG001

Interventions

JMT101 DRUG

JMT101 Q2W or Q3W, intravenous injection

Experimental Group 1; Experimental Group 2; JMT101 monotherapy; SYS6002 combinational therapy (Q2W); SYS6002 combinational therapy (Q3W)

SYS6002 DRUG

SYS6002 Q2W or Q3W, intravenous injection

Experimental Group 1; Experimental Group 2; Factorial Group; SYS6002 combinational therapy (Q2W); SYS6002 combinational therapy (Q3W); SYS6002 monotherapy (Q2W); SYS6002 monotherapy (Q3W)

SG001 DRUG

SG001 Q2W or Q3W, intravenous injection

Experimental Group 1; Experimental Group 2; Factorial Group; SYS6002 combinational therapy (Q2W); SYS6002 combinational therapy (Q3W)

Eligibility Criteria

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

You may qualify if:

• 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.
• Life expectancy ≥ 3 months.
• Normal major organ function within 7 days prior to treatment.

You may not qualify if:

• 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.
• Participants who have previously received MMAE toxin ADC treatment (only for Part 1 and Stage 2 in Part 2).
• 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.

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

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, factorial design

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 25, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-08