Clinical trial · Interventional
SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC
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)
NCT06989671CI-TRIAL-00094163not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JMT101 | Drug | — | UNRESOLVED |
| SG001 | Drug | — | UNRESOLVED |
| SYS6002 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- SYS6002 monotherapy (Q2W)
- interventionNames
- Drug: SYS6002
- type
- EXPERIMENTAL
- label
- SYS6002 monotherapy (Q3W)
- interventionNames
- Drug: SYS6002
- type
- EXPERIMENTAL
- label
- JMT101 monotherapy
- interventionNames
- Drug: JMT101
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.