Targeted drug combo aims to shrink Hard-to-Treat head and neck tumors
NCT ID NCT07683507
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study tests a new drug, becotatug vedotin, combined with an immunotherapy (PD-1 inhibitor) in adults with advanced head and neck squamous cell carcinoma that cannot be surgically removed. The drug targets a protein called EGFR on cancer cells and delivers a toxin directly to them. The trial includes two groups: people who have not had prior treatment for advanced disease and those who have received at least one prior therapy. The main goal is to see how many participants' tumors shrink or disappear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- becotatug vedotin combined with a PD-1 inhibitor
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced head and neck cancer, potentially shrinking tumors and delaying progression.
- What could go wrong
- This is an early-phase, single-arm study with only 60 participants. The drug may cause side effects, and results may not confirm benefit in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NeoRTPC02): an open label, single-arm, phase II clinical trial
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