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
NCT06509997 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-07-19
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Lei Liu
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
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