Head and Neck Squamous Cell CarcinomaPhase 2NCT06989671
SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC
A Phase 2 study testing JMT101, SYS6002 and SG001 in people with Head and Neck Squamous Cell Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- JMT101, SYS6002 and SG001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2025to 30 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read the 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- JMT101, SYS6002, SG001
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT101Drug
JMT101 Q2W or Q3W, intravenous injection
SYS6002Drug
SYS6002 Q2W or Q3W, intravenous injection
SG001Drug
SG001 Q2W or Q3W, intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| SYS6002 monotherapy (Q2W) | Experimental | Not described Receives: Drug: SYS6002 |
| SYS6002 monotherapy (Q3W) | Experimental | Not described Receives: Drug: SYS6002 |
| JMT101 monotherapy | Experimental | Not described Receives: Drug: JMT101 |
| SYS6002 combinational therapy (Q2W) | Experimental | Not described Receives: Drug: JMT101; Drug: SYS6002; Drug: SG001 |
| SYS6002 combinational therapy (Q3W) | Experimental | Not described Receives: Drug: JMT101; Drug: SYS6002; Drug: SG001 |
| Factorial Group | Experimental | Not described Receives: Drug: SYS6002; Drug: SG001 |
| Experimental Group 1 | Experimental | Not described Receives: Drug: JMT101; Drug: SYS6002; Drug: SG001 |
| Experimental Group 2 | Experimental | Not described Receives: Drug: JMT101; Drug: SYS6002; Drug: SG001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicities (DLTs)
Measured: Up to 28 days
Incidence of Adverse Events (AEs)
Measured: Up to approximately 2 years
Maximum Tolerated Dose (MTD)
Measured: Up to approximately 2 years
Objective Response Rate (ORR)
Measured: Up to approximately 2 years
Secondary outcomes (4)
Disease Control Rate (DCR)
Measured: Up to approximately 2 years
Duration of Response (DOR)
Measured: Up to approximately 2 years
Progression-free Survival (PFS)
Measured: Up to approximately 2 years
Overall Survival (OS)
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized, open-label, factorial design
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989671
- Sponsor's protocol ID
- SYS6002-003
- Status last verified
- Aug 2025
- First submitted
- 25 Apr 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06989671
- Acronym / sponsor ID
- SYS6002-003
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Randomized, open-label, factorial design
| Arm | Type | Receives |
|---|---|---|
| SYS6002 monotherapy (Q2W) | Experimental | Drug: SYS6002 |
| SYS6002 monotherapy (Q3W) | Experimental | Drug: SYS6002 |
| JMT101 monotherapy | Experimental | Drug: JMT101 |
| SYS6002 combinational therapy (Q2W) | Experimental | Drug: JMT101, Drug: SYS6002, Drug: SG001 |
| SYS6002 combinational therapy (Q3W) | Experimental | Drug: JMT101, Drug: SYS6002, Drug: SG001 |
| Factorial Group | Experimental | Drug: SYS6002, Drug: SG001 |
| Experimental Group 1 | Experimental | Drug: JMT101, Drug: SYS6002, Drug: SG001 |
| Experimental Group 2 | Experimental | Drug: JMT101, Drug: SYS6002, Drug: SG001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMT101JMT101 Q2W or Q3W, intravenous injection | Drug | Experimental Group 1, Experimental Group 2, JMT101 monotherapy, SYS6002 combinational therapy (Q2W), SYS6002 combinational therapy (Q3W) |
| SYS6002SYS6002 Q2W or Q3W, intravenous injection | Drug | Experimental Group 1, Experimental Group 2, Factorial Group, SYS6002 combinational therapy (Q2W), SYS6002 combinational therapy (Q3W), SYS6002 monotherapy (Q2W), SYS6002 monotherapy (Q3W) |
| SG001SG001 Q2W or Q3W, intravenous injection | Drug | Experimental Group 1, Experimental Group 2, Factorial Group, SYS6002 combinational therapy (Q2W), SYS6002 combinational therapy (Q3W) |
Primary outcome
Dose-limiting Toxicities (DLTs)
Time frame: Up to 28 days
Incidence of Adverse Events (AEs)
Time frame: Up to approximately 2 years
Maximum Tolerated Dose (MTD)
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Progression-free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JMT101, SYS6002 and SG001 in people with Head and Neck Squamous Cell Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.