Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck

NCT ID: NCT06959108

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2029-10-31

Brief Summary

The primary objective of this study is to compare the objective response rate (ORR) of patients with LA-HNSCC, treated with induction of EGFR-ADC MRG003 and anti PD-1 Pucotenlimab versus EGFR-ADC MRG003 alone before chemoradiotherapy.

People eligible to participate in this study must be between the ages of 18 and 75 and have locally advanced squamous cell carcinoma of the head and neck requiring treatment with chemoradiotherapy (cisplatin combined with radiotherapy).

Half of the research participants will receive MRG003 alone as induction before radiochemotherapy and the other half will receive MRG003 combined with pucotenlimab as induction before radiochemotherapy, then pucotenlimab as adjuvant* after radiochemotherapy.

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pucotenlimab-MRG003

• Induction treatment (9 weeks): 3 cycles of the anti-PD-1 Pucotenlimab in combination with the EGFR ADC MRG003
• Concurrent chemoradiation (7 weeks). The CRT will start within 28 ± 7 days after the Day 1 of the third cycle of the EGFR ADC MRG003.
• Adjuvant treatment (24 weeks from one month after the end of CRT).

Group Type: EXPERIMENTAL

Pucotenlimab

Intervention Type: DRUG

200mg every 3 weeks (21-day cycles) for a total of 3 cycles.

MRG003

Intervention Type: DRUG

2.3 mg/kg, every 3 weeks (21-day cycles) for a total of 3 cycles.

MRG003 alone

• Induction treatment ( 9 weeks): 3 cycles of the EGFR ADC MRG003 alone
• Concurrent chemoradiation (7 weeks). The CRT will start within 28 ± 7 days after the Day 1 of the third cycle of the EGFR ADC MRG003.

Group Type: ACTIVE_COMPARATOR

MRG003

Intervention Type: DRUG

2.3 mg/kg, every 3 weeks (21-day cycles) for a total of 3 cycles.

Interventions

Pucotenlimab

200mg every 3 weeks (21-day cycles) for a total of 3 cycles.

Intervention Type: DRUG

MRG003

2.3 mg/kg, every 3 weeks (21-day cycles) for a total of 3 cycles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Evaluable tumor burden assessed by H&N-computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on RECIST v 1.1
• Patients eligible to cisplatin-based chemotherapy
• No hearing loss by clinical assessment or ≤ grade 2 hearing impairment (according to NCICTCAE v.5
• No prior treatment with chemotherapy, immunotherapy and targeted therapy for H&N cancer, radiotherapy or surgery in the head and neck region.

Exclusion Criteria

• Metastatic disease (stage IVC as per AJCC/TNM, 8th Ed.).
• Patients having received prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2, anti- CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways).
• Treatment for other diseases with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment
• History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer outside the head and neck area or completely resected stage I breast cancer, or completely resected in-situ nonmuscular invasive bladder, cervix, uterine and/or prostate (Gleason 6) carcinomas, or T1a squamous cell carcinoma of the esophagus or rectum/anus.
• Patients with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, or known persistent reduced left ventricular ejection fraction < 50%.
• Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Patients with positive tests for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. Presence of other serious liver diseases, including chronic autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lepu Medical Technology (Beijing) Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Groupe Oncologie Radiotherapie Tete et Cou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean BOURHIS, Medical Director

Role: STUDY_DIRECTOR

GORTEC

Central Contacts

Marceline EMGOUE

Role: CONTACT

marceline.emgoue@gortec.fr

02 42 06 02 56 ext. +33

Laura SINIGAGLIA

Role: CONTACT

02 42 06 01 86 ext. +33

Other Identifiers

2023-510558-18-00

Identifier Type: CTIS

Identifier Source: secondary_id

GORTEC 2024-03

Identifier Type: -

Identifier Source: org_study_id