SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC

NCT06989671
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Phase
Phase 2
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Recruitment status
Not yet recruiting
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Participants
430
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Lead sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
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Start date
2025-08-30
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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.
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Short title
SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC
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Official title
A Phase 2 Study of SYS6002 in Combination With JMT101 and Enlonstobart Injection in Participants With Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-07-30
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First posted
2025-05-25
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Registry last updated
2025-08-27
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Primary completion date
2027-12-30
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Start date
2025-08-30
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Participants
430
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Participant count basis
Estimated
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Planned participants
430
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Protocol amendments
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06989671
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ClinicalTrials.gov ID
NCT06989671
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Registry record
Open registry record
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Allocation
Randomised
Model
Factorial
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Dose-limiting Toxicities (DLTs)

    Timeframe: Up to 28 days

  2. Incidence of Adverse Events (AEs)

    Timeframe: Up to approximately 2 years

  3. Maximum Tolerated Dose (MTD)

    Timeframe: Up to approximately 2 years

  4. Objective Response Rate (ORR)

    Timeframe: Up to approximately 2 years

  1. Disease Control Rate (DCR)

    Timeframe: Up to approximately 2 years

  2. Duration of Response (DOR)

    Timeframe: Up to approximately 2 years

  3. Progression-free Survival (PFS)

    Timeframe: Up to approximately 2 years

  4. Overall Survival (OS)

    Timeframe: Up to approximately 3 years

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)