Becotatug Vedotin Plus PD-1 Inhibitor for Head and Neck Squamous Cell Carcinoma (NCT07683507) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Becotatug Vedotin Plus PD-1 Inhibitor for Head and Neck Squamous Cell Carcinoma
60 participantsStarted 2026-07-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 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.