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A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma

NCT06530914•Lei Liu

View on ClinicalTrials.gov

Summary

A Randomized, Phase II Study of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma. This proposed study will evaluate the efficacy and safety of preoperative administration of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in HNSCC who are eligible for resection.

Detailed Description

In this study, eligible patients will be randomized in a 1:1 ratio to either the MRG003 Injection Combined With Pucotenlimab Injection treatment group (Cohort 1), or the MRG003 Injection Combined With Pucotenlimab Injection + Cisplatin treatment group (Cohort 2). Pathological response rate will be the primary outcome measures. Adverse events will also be recorded.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Sign the informed consent voluntarily and follow the requirements of the program;
•2. Age ≥18 years old, ≤70 years old, gender is not limited;
•3. Physical condition score ECOG 0 or 1;
•4. Histopathology confirmed the diagnosis of head and neck squamous cell carcinoma, and immunohistochemistry confirmed that EGFR expression was positive (defined as weak staining of \> 10% of tumor cells);
•5. No previous treatment for head and neck squamous cell carcinoma, including drug therapy, radiotherapy, surgery, etc., and the tumors of the subjects assessed by the researchers before admission could be surgically resected;
•6. According to the American Joint Committee on Cancer (AJCC) /TNM Staging System eighth Edition, patients must have the following tumor stages: 1) patients with stage III, IVA, and IVB non-oropharyngeal cancer and patients with HPV-negative oropharyngeal cancer; Or 2) Stage II and III HPV-positive oropharyngeal cancer patients. For patients with oropharyngeal cancer, HPV status should be determined by p16 IHC.
•7. The level of organ function must meet the following requirements:
•* Bone marrow: absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90 g/L, and no blood transfusion or biological response regulator (such as granulocyte, erythrocyte growth factor, etc.) treatment within 14 days before the first dose;
•* Liver: total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5×ULN; Serum albumin ≥28 g/L;
•* Kidney: creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula);
+3 more criteria

Exclusion Criteria

•1. Tumors originating from nasopharyngeal, paranasal, nasal or salivary glands, thyroid or parathyroid lesions, skin, unknown primary squamous cell carcinoma or non-squamous histology (e.g., mucosal melanoma);
•2. Peripheral neuropathy ≥ grade 2 (according to CTCAE v5.0);
•3. Have received any of the following treatments:
•* Received intravenous antibiotic therapy within 7 days prior to initial dosing;
•* Investigational drugs that have received other clinical trials within 4 weeks prior to initial dosing;
•* have received live attenuated vaccine within 4 weeks prior to first administration, and are allowed to receive inactivated seasonal influenza vaccine or approved COVID-19 vaccine without live virus;
•* Received systemic immunostimulatory drugs (including but not limited to interferon, interleukin-2, etc.) within 4 weeks prior to initial administration;
•* Had major surgery (e.g., transabdominal, thoracic, etc., excluding diagnostic puncture, infusion device implantation, or digestive home implantation) within 4 weeks prior to initial dosing, or expected to require major surgery during the study period; Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies (including ipilimumab) or any other antibody or drug that targets T-cell co-stimulation or immune checkpoint pathways;
•4. A history of other primary malignancies within the past 3 years, excluding basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ that has been completely and radically resected;
•5. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke/myocardial infarction, unstable angina, congestive heart failure (NYHA Class II and above), or severe arrhythmia requiring medication within the first 6 months of enrollment;
+8 more criteria

Key Dates

Start Date

August 1, 2024

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

July 31, 2024

Enrollment

ESTIMATED participants

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

MRG003 combined with Pucotenlimab

DRUG

MRG003 combined with Pucotenlimab+Cisplatin

DRUG

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

NCT04080804

Head and Neck Squamous Cell Carcinoma (HNSCC)

View study

RECRUITINGNA

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

NCT06630780

Head and Neck Squamous Cell Carcinoma (HNSCC)

View study

RECRUITINGPHASE1/PHASE2

AK129 Combination Therapy for Advanced Solid Tumors

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

AK129 Combination Therapy for Advanced Solid Tumors

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

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A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer