> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/sys6002-plus-jmt101-and-enlonstobart-injection-in-b3c65b80-c95e-4778-9c55-ec5dcedb72b7 > Record changed: 2026-10-13 # SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC NCT06989671 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) Participants 430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) Lead sponsor CSPC Megalith Biopharmaceutical Co.,Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) Start date 2025-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Short title** SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) ## Dates **Completion date** 2028-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **First posted** 2025-05-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Registry last updated** 2025-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Primary completion date** 2027-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Start date** 2025-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) ## Size and sites **Participants** 430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Planned participants** 430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Lead sponsor** CSPC Megalith Biopharmaceutical Co.,Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) ## Identifiers **Registry ID** NCT06989671 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **ClinicalTrials.gov ID** NCT06989671 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) ## Study design **Allocation** Randomised **Model** Factorial **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) ## Outcomes ### Primary outcomes 1. Dose-limiting Toxicities (DLTs) Timeframe: Up to 28 days 2. Incidence of Adverse Events (AEs) Timeframe: Up to approximately 2 years 3. Maximum Tolerated Dose (MTD) Timeframe: Up to approximately 2 years 4. Objective Response Rate (ORR) Timeframe: Up to approximately 2 years ### Secondary outcomes 1. Disease Control Rate (DCR) Timeframe: Up to approximately 2 years 2. Duration of Response (DOR) Timeframe: Up to approximately 2 years 3. Progression-free Survival (PFS) Timeframe: Up to approximately 2 years 4. Overall Survival (OS) Timeframe: Up to approximately 3 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989671) ## Related records ### Drugs (2) - [Becotatug](https://trialight.com/data/asset/becotatug-4202b488-cd68-4818-8f22-3085a6495e53.md) - [Enlonstobart](https://trialight.com/data/asset/enlonstobart-6441d39e-4fec-4bb7-ac06-e1f1ecd9f682.md) ### Lead sponsors (1) - [CSPC Megalith Biopharmaceutical Co.,Ltd.](https://trialight.com/data/company/cspc-megalith-biopharmaceutical-co-ltd-3e23baf5-2c63-4924-bd71-93a2333b9a1f.md) ### Conditions (1) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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