Status:
NOT_YET_RECRUITING
SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC
Lead Sponsor:
CSPC Megalith Biopharmaceutical Co.,Ltd.
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
This trial consists of two parts. Part 1 (Monotherapy Group) evaluates both SYS6002 monotherapy (stratified into two cohorts by dose levels and administration frequencies) and JMT101 monotherapy. Part...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2028
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT06989671
Start Date
August 30 2025
End Date
July 30 2028
Last Update
August 27 2025
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