SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JMT101, SYS6002, SG001.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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 2 (Combination Therapy Group) comprises Stage 1 (dose escalation phase) and Stage 2 (proof-of-concept phase). Following completion of the dose escalation phase in Part 2 and evaluation of integrated efficacy and safety analyses of SYS6002 monotherapy in Part 1 of this study as well as other clinical studies involving participants with ≥2L HNSCC, the decision on progressing to Stage 2 of Part 2 will be made through discussion between the Sponsor and investigators.
Interventions
- Drug JMT101
JMT101 Q2W or Q3W, intravenous injection - Drug SYS6002
SYS6002 Q2W or Q3W, intravenous injection - Drug SG001
SG001 Q2W or Q3W, intravenous injection
Primary outcome measures
- Dose-limiting Toxicities (DLTs) [Time frame: Up to 28 days]
- Incidence of Adverse Events (AEs) [Time frame: Up to approximately 2 years]
- Maximum Tolerated Dose (MTD) [Time frame: Up to approximately 2 years]
- Objective Response Rate (ORR) [Time frame: Up to approximately 2 years]
Secondary outcome measures (4)
- Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
- Duration of Response (DOR) [Time frame: Up to approximately 2 years]
- Progression-free Survival (PFS) [Time frame: Up to approximately 2 years]
- Overall Survival (OS) [Time frame: Up to approximately 3 years]
Eligibility criteria
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.
- Life expectancy ≥ 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06989671 · SYS6002-003