A Phase 2 interventional study of Becotatug Vedotin and Pucotenlimab in Hypopharyngeal Squamous Cell Carcinoma, sponsored by Tianjin Medical University Cancer Institute and Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment
This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-ADC) in combination with Pucotenlimab(Anti-PD-1 Monoclonal Antibody) as neoadjuvant therapy for patients with Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma.
The primary objective is the pathological complete response(pCR)rate following neoadjuvant therapy. The secondary objective includes the major pathological response(MPR)rate following neoadjuvant therapy, the objective response rate (ORR), Organ preservation rate, Surgery postponement rate, event-free survival (EFS), overall survival(OS), and safety.
This study is a multicenter, phase II clinical trial of neoadjuvant Becotatug Vedotin (EGFR-ADC) combined with Pucotenlimab (Anti-PD-1 monoclonal antibody) in patients with resectable locally advanced hypopharyngeal squamous cell carcinoma. Eligible participants will receive Becotatug Vedotin plus Pucotenlimab as preoperative neoadjuvant therapy, intravenous infusion every 3 weeks (Q3W) for 3 cycles.Tumor assessment will be performed after two cycles of neoadjuvant treatment. If, upon evaluation by the investigator, participants achieve a complete response (CR) based on radiographic assessment after two cycles, they may proceed directly to radical surgical resection. In the event of disease progression, severe adverse events, or intolerable toxicity during the neoadjuvant phase, the investigator may decide to discontinue neoadjuvant therapy and initiate radical therapy.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's planned enrollment of 52 is close to the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
Counted across the registry records on this site, refreshed daily.
3. Measurable primary lesions per RECIST v1.1; 5.Treatment-naive (no prior anti-tumor therapy for current disease); 6.ECOG performance status 0-1; 7.Estimated life expectancy >= 3 months; 8.Have adequate organ function as defined by laboratory parameters; 9.No contraindications to chemotherapy, targeted therapy, or immunotherapy; 10.No history of immune-related diseases; 11.No uncontrolled pneumonia or pulmonary infection; 12.Female participants of childbearing potential must agree to use effective contraception during the trial; A serum or urine pregnancy test must be negative within 72 hours prior to the start of chemotherapy; 13.The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program; Subjects are willing and able to follow the trial and follow-up procedures.
Exclusion Criteria:
Patients who have received any of the following treatments:
A. Receipt of any investigational drug or anti-cancer therapy within 4 weeks prior to the first dose of the study drug; B. Requirement for systemic treatment with corticosteroids (daily dose > 10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of the study drug.; C. Prior vaccination with an anti-tumor vaccine or receipt of a live vaccine within 4 weeks prior to the first dose of the study drug; D. Major surgery or significant traumatic injury within 4 weeks prior to the first dose of the study drug; E. Concurrent enrollment in another clinical study;
Drug: Becotatug Vedotin and Pucotenlimab
Neoadjuvant therapy: Becotatug Vedotin is dosed based on the participant's body weight. In this study, the dosing regimen is 2.3 mg/kg, administered via intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W), for a total of 3 treatment cycles. The infusion time for Becotatug Vedotin should be no less than 60min, and it is recommended to be controlled within 60 to 90min. Pucotenlimab is administered at a fixed dose of 200 mg per infusion, via intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W), for a total of 3 treatment cycles, with an infusion duration of 60min (±15 min). Becotatug Vedotin and Pucotenlimab are administered on the same day, Pucotenlimab is given first, followed by Becotatug Vedotin, with an interval of no less than 30min between the two infusions.
Also known as: Becotatug Vedotin(MRG003), Pucotenlimab(HX008)
Pathological Complete Response(pCR) Rate
The proportion of participants with no residual tumor cells in the resected primary tumor specimen after the completion of neoadjuvant therapy.
Time frame: At the time of surgery
Major Pathological Response(MPR) Rate
The proportion of participants who achieve a major pathological response, defined as residual viable tumor cells ≤ 10% in the resected primary tumor specimen following neoadjuvant therapy.
Time frame: At the time of surgery
Objective Response Rate（ORR）
The proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by RECIST version 1.1 after completion of neoadjuvant therapy.
Time frame: After 2 cycles or 3 cycles of neoadjuvant therapy
Event-Free Survival (EFS)
The time from the start of study treatment to the first occurrence of any of the following events, including but not limited to: disease progression precluding surgical treatment, local recurrence or distant metastasis, or death from any cause.
Time frame: From start of study treatment up to approximately 3 years
Overall Survival(OS)
The time from the start of study treatment to death from any cause.
Time frame: From start of study treatment up to approximately 5 years
Organ Preservation Rate
The proportion of participants in whom the surgical approach is optimized or the extent of surgery is reduced after neoadjuvant therapy, as determined by experienced surgeons comparing the feasible surgical approach based on baseline tumor assessment prior to neoadjuvant therapy with the feasible surgical approach after completion of neoadjuvant therapy.
Time frame: At the time of surgery
Surgery Postponement Rate
The proportion of subjects who did not undergo radical surgery within 6 weeks after the last dose of neoadjuvant therapy.
Time frame: 6 weeks after neoadjuvant therapy
Adverse Events (AEs)
Incidence, severity, and relationship to treatment of adverse events, as assessed by CTCAE criteria.
Time frame: From first dose of study treatment to 1 month after the last dose
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Squamous Cell Carcinoma of Head and Neck→
Tianjin Medical University Cancer Institute and Hospital