Neoadjuvant EGFR-ADC Combined With Anti-PD-1 Monoclonal Antibody in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma

NCT07665190 | Recruiting Phase 2

• 1 other identifier: RESERVE-HC
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypopharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  At the time of surgery

Secondary Outcomes (7)

• Major Pathological Response(MPR) Rate

  At the time of surgery

• Objective Response Rate（ORR）

  After 2 cycles or 3 cycles of neoadjuvant therapy

• Event-Free Survival (EFS)

  From start of study treatment up to approximately 3 years

• Overall Survival(OS)

  From start of study treatment up to approximately 5 years

• Organ Preservation Rate

  At the time of surgery

Study Arms (1)

Combination Therapy with Becotatug Vedotin and Pucotenlimab

EXPERIMENTAL

Drug: Becotatug Vedotin and Pucotenlimab

Interventions

Becotatug Vedotin and Pucotenlimab DRUG

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)

Combination Therapy with Becotatug Vedotin and Pucotenlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18, male or female;
• Histopathologically confirmed Hypopharyngeal Squamous Cell Carcinoma;
• Surgically resectable, Clinical Stage III or IV and no distant metastasis (AJCC 8th edition);
• \. 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.

You may not qualify if:

• Patients with distant metastasis;
• Patients with uncontrolled severe medical conditions;
• Patients with a history of allergy or hypersensitivity to any component of monoclonal antibody therapies;
• Uncontrolled cardiac clinical symptoms or diseases;
• Occurrence of severe infection (CTCAE Grade \> 2) within 4 weeks prior to the first dose of the study drug;
• Unexplained fever \> 38.5°C during the screening period or before the first dose;
• Active autoimmune disease or a history of autoimmune disease;
• History of immunodeficiency, or a history of organ transplantation or allogeneic bone marrow transplantation;
• Patients with untreated chronic hepatitis B, or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or patients with active hepatitis C virus (HCV) must be excluded;
• History of interstitial lung disease;
• Patients with active pulmonary tuberculosis infection identified by medical history or CT scan;
• 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;
• Dementia, altered mental status, or any psychiatric condition that would interfere with understanding or providing informed consent or completing questionnaires;
• Subjects with peripheral neuropathy ≥ Grade 2 according to CTCAE V5.0;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300000

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Xudong Wang

CONTACT

86+02223340123-3130; wxd.1133@163.com

Hongling Wang

CONTACT

86+02223340123-3130; wanghongling86@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All eligible participants will receive neoadjuvant therapy with Becotatug Vedotin plus Pucotenlimab for 3 cycles prior to surgery.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)