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Head and Neck Squamous Cell CarcinomaPhase 2NCT07683507

Becotatug Vedotin Plus PD-1 Inhibitor for Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing Becotatug Vedotin Combined with PD-1 Inhibitor in people with Head and Neck Squamous Cell Carcinoma, run by Feng Liu.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This is a prospective, open-label, non-randomized, two-cohort, single-arm Phase 2 study in adults with unresectable or recurrent/metastatic head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Becotatug Vedotin Combined with PD-1 Inhibitor
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 31 Dec 2029
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

  • Age 18 to 80 years.
  • Primary tumor of head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma.
  • Disease assessed as not suitable for complete surgical resection, or the participant refuses surgery despite being considered technically eligible for surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • No obvious contraindications to immunotherapy, radiotherapy, or chemotherapy.
  • Adequate major organ function, defined as follows:
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  • Hematologic function: 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, blood products, G-CSF, or other hematopoietic growth factors within 14 days before testing.
  • Biochemical function: 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 by the Cockcroft-Gault formula.
  • Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN. For participants receiving anticoagulant therapy, PT must be within the intended therapeutic range of the anticoagulant.
  • Women of childbearing potential must use reliable contraception, have a negative pregnancy test within 7 days before enrollment, and agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody. Male participants with female partners of childbearing potential must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody.
  • The participant voluntarily agrees to participate in the study, signs the informed consent form, and is willing and able to comply with study visits and follow-up.

Who cannot join

  • Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection; active hepatitis B infection, defined as HBV-DNA ≥10^4 copies/mL; or hepatitis C infection, defined as positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay.
  • Known allergy to the study drug or any of its excipients, or a history of severe hypersensitivity reaction to other monoclonal antibodies.
  • Any of the following within 6 months before the first dose of study treatment: myocardial infarction, severe or unstable angina, New York Heart Association (NYHA) class II or higher heart failure, or symptomatic congestive heart failure.
  • Receipt of a live vaccine within 4 weeks before the first dose of study treatment. Inactivated injectable vaccines for seasonal influenza are permitted, but intranasal live attenuated influenza vaccines are not permitted.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Known history of psychotropic drug abuse or illicit drug use.
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  • Pregnant or breastfeeding women.
  • Diagnosis of any other malignancy within 5 years before study entry, except for locally treated and cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma.
  • Any other serious physical or psychiatric illness or laboratory abnormality that may increase the risk of study participation, interfere with study results, or make the participant unsuitable for this study in the investigator's judgment.

About this study

Official title: A Clinical Study of the Efficacy and Safety of Becotatug Vedotin in Combination With Immune Checkpoint Inhibitors as First-Line or Later-Line Treatment for Head and Neck Squamous Cell Carcinoma

This is a prospective, open-label, non-randomized, two-cohort, single-arm Phase 2 study in adults with unresectable or recurrent/metastatic head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma. The study will evaluate the efficacy and safety of Becotatug vedotin, an EGFR-targeted antibody-drug conjugate, in combination with an investigator-selected PD-1 inhibitor. Participants will enter one of two cohorts based on prior treatment: those who have not received prior systemic treatment for unresectable or recurrent/metastatic disease, and those who have received at least one prior line of treatment. Becotatug vedotin will be given once every 21 days with the PD-1 inhibitor. Treatment may continue until disease progression, unacceptable side effects, withdrawal of consent, death, or other protocol-defined reasons. The main purpose is to assess objective response rate, defined as the percentage of participants whose tumors have a complete or partial response. Other outcomes include safety, tolerability, progression-free survival, overall survival, disease control rate, and duration of response.

Being tested
Becotatug Vedotin Combined with PD-1 Inhibitor
Keywords
Becotatug Vedotin, PD-1 Inhibitor, EGFR-Targeted Antibody-Drug Conjugate, Objective Response Rate
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.

  • Becotatug Vedotin Combined with PD-1 InhibitorDrug

    Becotatug vedotin will be administered at 2.0 mg/kg by intravenous infusion once every 3 weeks in combination with an investigator-selected PD-1 inhibitor. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or other protocol-defined reasons for discontinuation.

Study groups in NCT07683507
Study groupRoleWhat they receive
First-Line CohortExperimentalParticipants who have not received prior systemic treatment for unresectable or recurrent/metastatic head and neck squamous cell carcinoma.
Receives: Drug: Becotatug Vedotin Combined with PD-1 Inhibitor
Previously Treated CohortExperimentalParticipants who have received at least one prior line of systemic treatment for unresectable or recurrent/metastatic head and neck squamous cell carcinoma.
Receives: Drug: Becotatug Vedotin Combined with PD-1 Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Objective response rate is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as assessed by investigators according to RECIST v1.1. ORR will be evaluated separately in each cohort.

    Measured: From enrollment until disease progression, death, withdrawal of consent, start of new anti-cancer therapy, loss to follow-up, or end of study, up to 2 years.

Secondary outcomes (6)

  1. Progression-Free Survival (PFS)

    Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first.

    Measured: From enrollment to disease progression or death from any cause, up to 2 years.

  2. 1-Year and 2-Year Progression-Free Survival Rate

    The 1-year and 2-year progression-free survival rates are defined as the percentage of participants who remain alive and free of disease progression at 1 year and 2 years after enrollment.

    Measured: At 1 year and 2 years after enrollment.

  3. 1-Year and 2-Year Overall Survival Rate

    The 1-year and 2-year overall survival rates are defined as the percentage of participants who remain alive at 1 year and 2 years after enrollment.

    Measured: At 1 year and 2 years after enrollment.

  4. Duration of Response (DoR)

    Duration of response is defined as the time from the first documented CR or PR to the first documented disease progression or death from any cause, whichever occurs first. This measure will be evaluated in participants who achieve CR or PR.

    Measured: From the first documented CR or PR to disease progression or death from any cause, up to 2 years.

  5. Disease Control Rate (DCR)

    Disease control rate is defined as the percentage of participants who achieve CR, PR, or stable disease (SD) as assessed by investigators according to RECIST v1.1. DCR will be evaluated separately in each cohort.

    Measured: From enrollment until disease progression, death, withdrawal of consent, start of new anti-cancer therapy, loss to follow-up, or end of study, up to 2 years.

  6. Incidence and Severity of Adverse Events

    Adverse events (AEs), serious adverse events (SAEs), immune-related adverse events, adverse events of special interest, infusion-related reactions, laboratory abnormalities, vital signs, physical examination findings, electrocardiogram findings, and echocardiography findings will be evaluated and summarized by severity, relationship to study treatment, action taken, and outcome. AEs will be graded according to NCI-CTCAE v5.0 and coded using MedDRA.

    Measured: From signing informed consent to 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.

  1. First posted6 Jul 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07683507
Sponsor's protocol ID
SH9H-2026-T260-2
Status last verified
Jun 2026
First submitted
29 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Becotatug Vedotin Combined with PD-1 Inhibitor in people with Head and Neck Squamous Cell Carcinoma, run by Feng Liu.

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 11 inclusion and 9 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 6 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 enrollment until disease progression, death, withdrawal of consent, start of new anti-cancer therapy, loss to follow-up, or end of study, up to 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07683507.

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 6 Jul 2026.

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