Head and Neck Squamous Cell Carcinoma
Conditions
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.
Interventions
Sponsors
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, open-label, factorial design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | Up to approximately 2 years |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
Primary ContactClinical Trials Information Group officer
Outcome results
None listed