NCT06989671Not yet recruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 27 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 430 (estimated)
- First submitted
- 25 Apr 2025
- Start date
- 30 Aug 2025
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Diseases
- Head and neck cancer
- NCT number
- NCT06989671
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 430
- From 30 Aug 2025 to the primary completion date, 30 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (Only for Stage 2 in Part 2) Prior systemic anti-tumor therapy for recurrent or metastatic HNSCC.
- 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.
- 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.
Other illness
- Known allergy to any component of SYS6002, JMT101, or Enlonstobart injection.
- Any serious and/or uncontrolled comorbid conditions that may interfere with the participant's ability to participate in the study
Other
- 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.
- Unwilling or unable to comply with the study procedures and requirements, or deemed unsuitable for participation by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.