Recurrent or Metastatic Head and Neck CarcinomaPhase 2NCT07686588
Sacituzumab Tirumotecan Plus Immunotherapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Sacituzumab Tirumotecan Plus Immune Checkpoint Inhibitor in people with Recurrent or Metastatic Head and Neck Carcinoma, run by Biying Chen.
Trial summary
This is a single-center, open-label phase 2 study evaluating sacituzumab tirumotecan in combination with an immune checkpoint inhibitor in patients with previously treated recurrent or metastatic head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent or Metastatic Head and Neck Carcinoma
- What is being tested?
- Sacituzumab Tirumotecan Plus Immune Checkpoint Inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years and <80 years at the time of signing the informed consent form.
- Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma, including locally recurrent disease not amenable to curative local therapy and distant metastatic disease.
- Recurrent or metastatic head and neck squamous cell carcinoma after failure of prior standard therapy containing an immune checkpoint inhibitor. Treatment failure is defined as discontinuation of the current treatment due to disease progression. For patients with recurrent or metastatic disease, disease progression (PD) confirmed during systemic therapy or at the first tumor response assessment after completion of therapy will be considered treatment failure. Dose adjustment, treatment switching, or treatment discontinuation due to drug intolerance, treatment-related toxicity, patient preference, financial reasons, or other non-progression-related reasons will not be considered treatment failure.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No clinically significant contraindication to immune checkpoint inhibitor therapy as judged by the investigator.
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- Adequate major organ function, meeting the following criteria:
- Hematology: white blood cell count (WBC) ≥4.0 × 10^9/L, absolute neutrophil count (ANC) ≥1.5 × 10^9/L, platelet count (PLT) ≥100 × 10^9/L, and hemoglobin (Hb) ≥90 g/L, without blood transfusion or blood products and without granulocyte colony-stimulating factor (G-CSF) or other hematopoietic growth factors within 14 days before assessment.
- Serum chemistry: serum albumin ≥3.0 g/dL (30 g/L), total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN, and blood urea nitrogen (BUN) and serum creatinine (Cr) ≤1.5 × ULN, or creatinine clearance ≥60 mL/min calculated using the Cockcroft-Gault formula.
- Coagulation: adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN. For patients receiving anticoagulant therapy, PT must be within the intended therapeutic range for the anticoagulant.
- Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and agree to use effective contraception during the study and for 6 months after the last dose of study treatment. Male patients with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose of study treatment.
- Able to understand and voluntarily sign the informed consent form, and willing to comply with study procedures and follow-up.
Who cannot join
- Participation in another interventional drug clinical trial within 4 weeks before enrollment.
- Prior treatment with a TROP2-targeted therapy and/or a topoisomerase I inhibitor.
- Prior intolerance to immune checkpoint inhibitor therapy, defined as permanent discontinuation of prior immunotherapy due to a grade ≥3 immune-related adverse event (irAE) according to CTCAE v5.0, or hypersensitivity to an immune checkpoint inhibitor, including grade ≥3 infusion-related reaction.
- History of another malignancy within 5 years before enrollment, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
- Known history of hypersensitivity to any study drug or any of its components.
- Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
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- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Receipt of a live vaccine within 30 days before the first dose of study treatment.
- History of noninfectious interstitial lung disease (ILD) or noninfectious pneumonitis requiring steroid treatment; current ILD or noninfectious pneumonitis; or suspected ILD or noninfectious pneumonitis that cannot be excluded by imaging during screening. Patients with clinically significant pulmonary impairment due to comorbid pulmonary disease, including but not limited to pulmonary embolism within 3 months before the first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, or pleural effusion, or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs, such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis, or history of total pneumonectomy, are also excluded.
- Active autoimmune disease requiring systemic treatment within the past 2 years. Hormone replacement therapy is not considered systemic treatment, including type 1 diabetes mellitus, hypothyroidism requiring only thyroid hormone replacement, or adrenal or pituitary insufficiency requiring only physiologic corticosteroid replacement.
- Active infection requiring systemic therapy within 2 weeks before the first dose of study treatment.
- Any serious concomitant disease that, in the investigator's judgment, may compromise patient safety or interfere with completion of the study, including but not limited to uncontrolled hypertension, severe diabetes mellitus, or active infection.
- Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that may impair or delay corneal healing.
- Pregnant or breastfeeding women; female patients of childbearing potential with a positive pregnancy test at baseline; or female patients of childbearing potential who are unwilling to use effective contraception during study treatment and for 6 months after the last dose of study treatment.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
About this study
Official title: A Prospective, Single-Center, Open-Label Phase II Clinical Study of Sacituzumab Tirumotecan Combined With Immune Checkpoint Inhibitors for the Later-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
This is a single-center, open-label phase 2 study evaluating sacituzumab tirumotecan in combination with an immune checkpoint inhibitor in patients with previously treated recurrent or metastatic head and neck squamous cell carcinoma.
Eligible patients will have recurrent or metastatic head and neck squamous cell carcinoma that has progressed after prior standard therapy including an immune checkpoint inhibitor. Sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate, will be administered by intravenous infusion every 2 weeks in combination with the patient's ongoing immune checkpoint inhibitor. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anticancer therapy, investigator decision, or other protocol-defined discontinuation criteria.
The primary endpoint is objective response rate (ORR), as assessed by the investigator according to RECIST v1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety and tolerability.
- Being tested
- Sacituzumab Tirumotecan Plus Immune Checkpoint Inhibitor
- Keywords
- Sacituzumab Tirumotecan, TROP2-Directed Antibody-Drug Conjugate, Immunotherapy Rechallenge, PD-1 Inhibitor, Phase 2 Study
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Tirumotecan Plus Immune Checkpoint InhibitorDrug
Participants will receive sacituzumab tirumotecan 5 mg/kg by intravenous infusion once every 2 weeks in combination with an immune checkpoint inhibitor. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anticancer therapy, investigator decision, or other protocol-defined discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Tirumotecan Plus Immune Checkpoint Inhibitor | Experimental | Participants will receive sacituzumab tirumotecan 5 mg/kg by intravenous infusion once every 2 weeks in combination with an immune checkpoint inhibitor. Receives: Drug: Sacituzumab Tirumotecan Plus Immune Checkpoint Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST v1.1.
Measured: From the first dose of study treatment until disease progression, initiation of new anticancer therapy, withdrawal of consent, death, or end of study, assessed up to 24 months.
Secondary outcomes (6)
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD), as assessed by the investigator according to RECIST v1.1.
Measured: From the first dose of study treatment until disease progression, initiation of new anticancer therapy, withdrawal of consent, death, or end of study, up to 24 months.
Duration of Response (DoR)
DoR is defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression or death from any cause, whichever occurs first, as assessed by the investigator according to RECIST v1.1. DoR will be analyzed only in participants who achieve CR or PR.
Measured: From the first documented CR or PR until disease progression, death, or end of study, up to 24 months.
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first. Disease progression will be assessed by the investigator according to RECIST v1.1.
Measured: From the first dose of study treatment until disease progression, death, or end of study, up to 24 months.
6-Month Progression-Free Survival Rate
The 6-month progression-free survival rate is defined as the estimated proportion of participants who remain alive without documented disease progression 6 months after the first dose of study treatment. Disease progression will be assessed by the investigator according to RECIST v1.1. The 6-month PFS rate will be estimated using the Kaplan-Meier method.
Measured: At 6 months after the first dose of study treatment.
Overall Survival (OS)
OS is defined as the time from the first dose of study treatment to death from any cause.
Measured: From the first dose of study treatment until death from any cause or end of study, up to 24 months.
Incidence and Severity of Adverse Events (AEs)
Safety will be evaluated by the incidence, severity, seriousness, and relationship to study treatment of adverse events, including treatment-emergent adverse events (TEAEs), treatment-related adverse events, grade ≥3 adverse events, serious adverse events (SAEs), adverse events leading to dose modification or treatment discontinuation, and adverse events of special interest. Adverse events will be graded according to NCI-CTCAE v5.0 and coded using MedDRA.
Measured: From the first dose of study treatment through 90 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Head and Neck CarcinomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biying Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Biying Chen, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686588
- Sponsor's protocol ID
- SH9H-2026-T205-2
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Open-Label Phase II Clinical Study of Sacituzumab Tirumotecan Combined With Immune Checkpoint Inhibitors for the Later-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07686588
- Acronym / sponsor ID
- SH9H-2026-T205-2
- Keywords
- Sacituzumab Tirumotecan, TROP2-Directed Antibody-Drug Conjugate, Immunotherapy Rechallenge, PD-1 Inhibitor, Phase 2 Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Biying ChenUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Jul 2026 (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 single-center, open-label phase 2 study evaluating sacituzumab tirumotecan in combination with an immune checkpoint inhibitor in patients with previously treated recurrent or metastatic head and neck squamous cell carcinoma.
Eligible patients will have recurrent or metastatic head and neck squamous cell carcinoma that has progressed after prior standard therapy including an immune checkpoint inhibitor. Sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate, will be administered by intravenous infusion every 2 weeks in combination with the patient's ongoing immune checkpoint inhibitor. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anticancer therapy, investigator decision, or other protocol-defined discontinuation criteria.
The primary endpoint is objective response rate (ORR), as assessed by the investigator according to RECIST v1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Tirumotecan Plus Immune Checkpoint Inhibitor | Experimental | Drug: Sacituzumab Tirumotecan Plus Immune Checkpoint InhibitorParticipants will receive sacituzumab tirumotecan 5 mg/kg by intravenous infusion once every 2 weeks in combination with an immune checkpoint inhibitor. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patients aged ≥18 years and <80 years at the time of signing the informed consent form.
- Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma, including locally recurrent disease not amenable to curative local therapy and distant metastatic disease.
- Recurrent or metastatic head and neck squamous cell carcinoma after failure of prior standard therapy containing an immune checkpoint inhibitor. Treatment failure is defined as discontinuation of the current treatment due to disease progression. For patients with recurrent or metastatic disease, disease progression (PD) confirmed during systemic therapy or at the first tumor response assessment after completion of therapy will be considered treatment failure. Dose adjustment, treatment switching, or treatment discontinuation due to drug intolerance, treatment-related toxicity, patient preference, financial reasons, or other non-progression-related reasons will not be considered treatment failure.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (15 listed)
- Participation in another interventional drug clinical trial within 4 weeks before enrollment.
- Prior treatment with a TROP2-targeted therapy and/or a topoisomerase I inhibitor.
- Prior intolerance to immune checkpoint inhibitor therapy, defined as permanent discontinuation of prior immunotherapy due to a grade ≥3 immune-related adverse event (irAE) according to CTCAE v5.0, or hypersensitivity to an immune checkpoint inhibitor, including grade ≥3 infusion-related reaction.
- History of another malignancy within 5 years before enrollment, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
- Known history of hypersensitivity to any study drug or any of its components.
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 |
|---|---|---|
| Sacituzumab Tirumotecan Plus Immune Checkpoint InhibitorParticipants will receive sacituzumab tirumotecan 5 mg/kg by intravenous infusion once every 2 weeks in combination with an immune checkpoint inhibitor. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anticancer therapy, investigator decision, or other protocol-defined discontinuation criteria. | Drug | Sacituzumab Tirumotecan Plus Immune Checkpoint Inhibitor |
Primary outcome
Objective Response Rate (ORR)
Time frame: From the first dose of study treatment until disease progression, initiation of new anticancer therapy, withdrawal of consent, death, or end of study, assessed up to 24 months.
ORR is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST v1.1.
6 secondary outcomes
Disease Control Rate (DCR)
Time frame: From the first dose of study treatment until disease progression, initiation of new anticancer therapy, withdrawal of consent, death, or end of study, up to 24 months.
Duration of Response (DoR)
Time frame: From the first documented CR or PR until disease progression, death, or end of study, up to 24 months.
Progression-Free Survival (PFS)
Time frame: From the first dose of study treatment until disease progression, death, or end of study, up to 24 months.
6-Month Progression-Free Survival Rate
Time frame: At 6 months after the first dose of study treatment.
Overall Survival (OS)
Time frame: From the first dose of study treatment until death from any cause or end of study, up to 24 months.
Incidence and Severity of Adverse Events (AEs)
Time frame: From the first dose of study treatment through 90 days after the last dose of study treatment
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 7 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Tirumotecan Plus Immune Checkpoint Inhibitor in people with Recurrent or Metastatic Head and Neck Carcinoma, run by Biying Chen.
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 12 inclusion and 15 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 7 Jul 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From the first dose of study treatment until disease progression, initiation of new anticancer therapy, withdrawal of consent, death, or end of study, assessed up to 24 months.). 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 7 Jul 2026.