ImmunoADC Therapy for Induction Conversion in Patients With Stage IVB OSCC/OPSCC

NCT07844551 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Transforming
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of Becotatug Vedotin (EGFR-targeted ADC, MRG003) plus Pucotenlimab (PD-1 inhibitor), compared with platinum-based chemotherapy/chemoradiotherapy, as an induction conversion regimen for downstaging primary stage IVB oral squamous cell carcinoma or HPV16-negative oropharyngeal squamous cell carcinoma.

Conditions

Stage IVB Oral Cavity Squamous Cell Carcinoma; Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Keywords

Combination of immunotherapy and antibody-drug conjugate; Stage IVB OSCC or OPSCC; Induction conversion

Outcome Measures

Primary Outcomes (1)

• Clinical downstaging rate

  The ratio of patients could achieve clinical downstaging after two cycles of drug treatment according to the AJCC 8th edition.

  6 months

Secondary Outcomes (3)

• Surgical R0 resection rate

  6 months

• Rate of 2-year overall survival

  2 years

• Rate of 2-year progression free survival

  2 years

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Combination therapy of immunotherapy and antibody-drug conjugate. Drugs: Becotatug vedotin: 2.3 mg/kg by intravenous infusion once every 21 days. Pucotenlimab: 200 mg by intravenous infusion once every 21 days. Each treatment cycle is 21 days, and two cycles will be administered. On each dosing day, pucotenlimab will be infused first, followed by becotatug vedotin.

Drug: Becotatug Vedotin (MRG003); Drug: Pucotenlimab

Control Arm

ACTIVE COMPARATOR

Participants in the control arm will undergo MDT assessment by the investigators and receive a platinum-based induction chemotherapy regimen. Cisplatin: 75mg/m2 by intravenous infusion once every 21 days. Each treatment cycle is 21 days, and two cycles will be administered. All required assessments must be completed within 3 days before dosing. Treatment may continue only after the safety evaluation is satisfactory.

Drug: Cisplatin

Interventions

Becotatug Vedotin (MRG003) DRUG

2.3 mg/kg by intravenous infusion once every 21 days

Experimental Arm

Pucotenlimab DRUG

200 mg by intravenous infusion once every 21 days

Experimental Arm

Cisplatin DRUG

75mg/m2 by intravenous infusion once every 21 days

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
• Histopathologically confirmed oral/oropharyngeal squamous cell carcinoma, including tumors of the tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar trigone, base of tongue, soft palate, or parapharyngeal region;
• Clinical stage IVB (cT1-4N3M0 or cT4bN0-3M0, AJCC 8th edition);
• At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
• Complete blood count: white blood cell count \>3,000/mm3, hemoglobin \>8 g/L, and platelet count \>80,000/mm3;
• Hepatic function: alanine aminotransferase/aspartate aminotransferase (ALT/AST) \<2.5 times the upper limit of normal (ULN), and bilirubin \<1.5 times the ULN;
• Renal function: serum creatinine \<1.5 times the ULN;
• Positive PD-L1 expression (combined positive score \[CPS\] \>=1) and positive EGFR expression (immunohistochemistry \[IHC\] 2+ or 3+);
• Written informed consent provided.

You may not qualify if:

• Unresolved toxicity of grade 2 or higher due to prior anticancer therapy;
• Known grade 3-4 hypersensitivity reaction to any study treatment;
• Active severe clinical infection (\>grade 2 infection according to NCI-CTCAE version 5.0);
• Uncontrolled hypertension or active cardiovascular disease, including cerebrovascular accident within 6 months before randomization, myocardial infarction within 6 months before randomization, unstable angina, congestive heart failure of New York Heart Association (NYHA; Appendix 5) class II or higher, or a serious arrhythmia that cannot be controlled with medication or may potentially affect study treatment;
• Active autoimmune disease requiring systemic immunomodulatory or corticosteroid therapy for a chronic condition (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants). Replacement therapy, such as thyroxine, insulin, or physiologic glucocorticoid replacement for adrenal or pituitary insufficiency, is not considered systemic therapy;
• History of another malignancy and its treatment;
• History of radiotherapy to the maxillofacial and neck region;
• HPV-positive oropharyngeal cancer;
• Pregnant or breastfeeding women;
• Known history of human immunodeficiency virus (HIV) infection, or uncontrolled active hepatitis B, defined as hepatitis B surface antigen (HBsAg) positivity together with a detectable hepatitis B virus DNA (HBV-DNA) copy number above the upper limit of normal of the local laboratory at the study center;
• Participation in another clinical study within 30 days before enrollment;
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Sponsors & Collaborators

• Huashan Hospital: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Lai-ping Zhong

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lai-ping Zhong, MD, PhD

CONTACT

+862152888915; zhonglp@hotmail.com

Ying-ying Huang, MD, PhD

CONTACT

+862152889999; kqyxyhyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years after completion of the trial, for 6 months.
• Access Criteria: Access to IPD data can be obtained upon scientifically sound request from the study PI, who will contact the Clinical Research Unit, Huashan Hospital, Fudan University. Access will be released after the approval from the Clinical Research Unit.