sys6002 plus jmt101 and enlonstobart injection as first-line treatment for hnscc

Conditions: Head and Neck Squamous Cell Carcinoma

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 patients with advanced head and neck squamous cell carcinoma who have not received previous systemic treatment

this trial is divided into two parts. part 1 (combination therapy group) consists of stage 1 (dose escalation) and stage 2 (proof of conception study), in which stage 2 adopts a randomized, controlled, open-label, multicenter design; part 2 (monotherapy group) is sys6002 monotherapy, divided into two cohorts with different dose groups. after completing the dose escalation of part 1 (combination therapy group), and combining with the efficacy and safety data of sys6002 monotherapy in part 2 of this study and other clinical studies in participants with ≥2l hnscc, the decision to enter stage 2 in part i (combination therapy group) will be made by discussion between the sponsor and the investigator.

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. * expected survival time of ≥ 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 part 1) 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 2 participants). * 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.