NCT06509997

A Phase II Study of Anti-EGFR Antibody-drug Conjugate (ADC) Combine With CDK4/6 Inhibitors Posterior Line in the Treatment of Recurrent/Metastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma

MRG003 Combined With Dalpicicilip Posterior Line in the Treatment of Recurrent/Metastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma: A Phase II Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Lei Liu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Single-arm, Phase II Study of MRG003 combined with Dalpicicilip posterior line in the treatment of recurrent/metastatic CDKN2A gene variant head and neck squamous cell carcinoman (HNSCC). The objective of this study was to evaluate the safety and efficacy of MRG003 combined with the Dalpicicilip posterior line in the treatment of recurrent/metastatic CDKN2A gene variant HNSCC.

Detailed description

In this study, patients meeting the inclusion criteria were given MRG003 (D1, IVGTT, Q3W) in combination with Darcilil (D1-21, PO, Q4W) after completing the relevant pre-treatment examination until progression or intolerable toxicity occurred. Objective response rate and safety will be the primary outcome measures. Adverse events will also be recorded.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	MRG003 combined with Dalpicicilip	MRG003, intravenous infusion, D1, once every 3 weeks; Dalpicicilip, taking orally, D1-21, once every 4 weeks, maintain use until progression or emergence of intolerable toxicity.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-07-19
• Last updated: 2024-07-19