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

June 29, 2026 updated by: Feng Liu

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: First-Line Cohort
Participants who have not received prior systemic treatment for unresectable or recurrent/metastatic head and neck squamous cell carcinoma.
Drug: Becotatug Vedotin Combined with PD-1 Inhibitor
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.
Experimental: Previously Treated Cohort
Participants who have received at least one prior line of systemic treatment for unresectable or recurrent/metastatic head and neck squamous cell carcinoma.
Drug: Becotatug Vedotin Combined with PD-1 Inhibitor
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From enrollment to disease progression or death from any cause, up to 2 years.
Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first.
From enrollment to disease progression or death from any cause, up to 2 years.
1-Year and 2-Year Progression-Free Survival Rate
Time Frame: At 1 year and 2 years after enrollment.
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.
At 1 year and 2 years after enrollment.
1-Year and 2-Year Overall Survival Rate
Time Frame: At 1 year and 2 years after enrollment.
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.
At 1 year and 2 years after enrollment.
Duration of Response (DoR)
Time Frame: From the first documented CR or PR to disease progression or death from any cause, up to 2 years.
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.
From the first documented CR or PR to disease progression or death from any cause, up to 2 years.
Disease Control Rate (DCR)
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.
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.
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.
Incidence and Severity of Adverse Events
Time Frame: From signing informed consent to 90 days after the last dose of study treatment.
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.
From signing informed consent to 90 days after the last dose of study treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Feng Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SH9H-2026-T260-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings