Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma

NCT07586124 | Not Yet Recruiting Phase 2

• 1 other identifier: HX008/MRG003-C004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 15

Brief Summary

A multicenter, randomized, double-blind, phase II clinical study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of Becotatug Vedotin for Injection in combination with PD-1 in patients with locally advanced resectable head and neck squamous cell carcinoma

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Pucotenlimab; Becotatug Vedotin

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response (MPR) Rate

  From date of surgery until completion of postoperative pathological assessment, up to 8 weeks

Secondary Outcomes (10)

• Pathological Complete Response (pCR) Rate

  From date of surgery until completion of postoperative pathological assessment, up to 8 weeks

• Event-Free Survival (EFS)

  From date of randomization until the date of disease progression/recurrence with initiation of new anti-tumor therapy, or death from any cause, whichever came first, assessed up to 24 months

• Overall Survival (OS)

  From date of randomization until death from any cause, assessed up to 36 months

• Preoperative Objective Response Rate (ORR)

  preoperative ORR will be assessed up to 12 weeks post-randomization

• actual surgical resection rate

  surgical resection rate will be evaluated perioperatively

Study Arms (2)

locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab

EXPERIMENTAL

Drug: Becotatug Vedotin for Injection; Drug: Pucotenlimab Injection

locally advanced resectable HNSCC Placebo +Pucotenlimab

PLACEBO COMPARATOR

Drug: Placebo; Drug: Pucotenlimab Injection

Interventions

Becotatug Vedotin for Injection DRUG

Administrated intravenously

locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab

Placebo DRUG

Administrated intravenously

locally advanced resectable HNSCC Placebo +Pucotenlimab

Pucotenlimab Injection DRUG

Administrated intravenously

locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab; locally advanced resectable HNSCC Placebo +Pucotenlimab

Eligibility Criteria

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

You may qualify if:

• Life expectancy ≥ 6 months.
• Subjects with histologically confirmed, resectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent surgery.
• At least one extracranial measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• No severe cardiac dysfunction.
• Must provide tumor tissue sample not previously subjected to radiotherapy.
• Adequate organ function.
• Subjects of childbearing potential must use effective contraception during the study and for 180 days after the last dose.

You may not qualify if:

• Primary tumor originating from nasopharynx, nasal cavity, paranasal sinuses, salivary gland, thyroid/parathyroid gland, skin, or unknown primary site (squamous cell carcinoma).
• Head and neck cancer deemed non-resectable by the investigator.
• Prior treatment with anti-PD-1, anti-PD-L1, MMAE/MMAF-based ADC agents, or other T-cell immune checkpoint inhibitors.
• Prior radiotherapy, systemic anti-tumor therapy, or other investigational therapy for head and neck cancer before study entry.
• Major surgery within 4 weeks before study entry, or not fully recovered from surgical toxicities/complications. Minor procedures (e.g., vascular access placement, percutaneous/endoscopic head/neck biopsy, tracheostomy tube exchange) are allowed.
• Grade ≥2 peripheral neuropathy (CTCAE v5.0).
• Active autoimmune disease requiring systemic treatment within 2 years before first dose.
• Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 2 weeks before first dose.
• Radiologically detectable central nervous system metastases and/or carcinomatous meningitis.
• Uncontrolled pleural, peritoneal, pelvic effusion, or pericardial effusion.
• Any severe or uncontrolled systemic disease.
• Prior or planned allogeneic tissue/solid organ transplantation.
• Known hypersensitivity to any active ingredient or excipient of the study drugs.
• Evidence of active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• Anti-infective therapy within 2 weeks before randomization.

Sponsors & Collaborators

• Lepu Biopharma Co., Ltd.: lead

Study Sites (15)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

Location

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Liaoning Cancer Hospital & institute

Shenyang, Liaoning, 110042, China

Location

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, 315040, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Program Director

CONTACT

86-21- 67680899; ra_bj@lepubiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)