SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC
Phase 2
Not yet recruiting
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT06989671
- Lead Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 430
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description SYS6002 monotherapy (Q2W) SYS6002 - SYS6002 monotherapy (Q3W) SYS6002 - JMT101 monotherapy JMT101 - SYS6002 combinational therapy (Q2W) JMT101 - SYS6002 combinational therapy (Q2W) SYS6002 - SYS6002 combinational therapy (Q2W) SG001 - SYS6002 combinational therapy (Q3W) JMT101 - SYS6002 combinational therapy (Q3W) SYS6002 - SYS6002 combinational therapy (Q3W) SG001 - Factorial Group SYS6002 - Factorial Group SG001 - Experimental Group 1 JMT101 - Experimental Group 1 SYS6002 - Experimental Group 1 SG001 - Experimental Group 2 JMT101 - Experimental Group 2 SYS6002 - Experimental Group 2 SG001 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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