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.
18 years old ≤75 years old;
Patients with recurrent or metastatic head and neck squamous cell carcinoma (including oral cavity, oropharynx, hypopharynx, larynx, etc.) confirmed by histology or cytology, recurrent patients cannot receive local treatment such as surgery or radiotherapy, and have failed to receive PD-1 (L1) inhibitors and/or platinum drugs in the past, which can be first-line combination regimens or sequential administration. Progression after receiving PD-1 (L1) inhibitors and/or platinum-based drugs;
Receive ≤2 lines of treatment;
ECOG score 0~1;
≥ grade 2 peripheral neuropathy (according to CTCAE 5.0).
Surgery or any other form of systemic or local anti-tumor therapy, including maintenance therapy or radiotherapy for head and neck squamous cell carcinoma (including palliative care, except palliative care for non-target lesions), is expected to be required during the study period.
Systematic chemotherapy was received within 3 weeks before the first administration of the drug, small molecule targeted therapy was received within 2 weeks before the first administration or 5 half-lives (depending on the time), antitumor biotherapy, macromolecule targeted therapy or immunotherapy was received within 4 weeks before the first administration of the drug. Or major surgery (except minor surgery performed within 2 weeks and complete recovery); Radiotherapy was received within 14 days prior to initial administration of the investigational drug (except for central nervous system radiotherapy, which required a washout period of ≥28 days).
Progressive or new neurological deficits, seizures, evidence of increased intracranial pressure, vomiting, or headache;
Lei Liu
Lead sponsor
West China Hospital
Sponsor institution