The goal of this prospective, single-center, open-label, dose-escalation study is to evaluate the safety, tolerability, and preliminary efficacy of CD-001 in patients with advanced head and neck cancers who have experienced disease progression (PD) or intolerance to standard systemic therapy (or lack thereof). The main question\[s\] it aims to answer:
* What is the safety and tolerability profile of CD-001 across escalating doses? * What is the preliminary efficacy of CD-001 in this patient population?
Age ≥ 18 years , regardless of gender.
Patients with advanced head and neck cancer that are histologically or cytological confirmed, lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.
ECOG score ≤ 2.
At least one measurable lesion as defined by RECIST v1.1.
Patients with known active central nervous system (CNS) and/or leptomeningeal metastases .
Patients who have undergone major organ surgery within 4 weeks prior to the first dosing, or who are expected to require major surgery during this study, or who have severe unhealed wounds, trauma, ulcers, etc.
Patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant.
Patients who have a past or current history of active or chronic autoimmune disease and who have required systemic therapy within the past 2 years or is receiving systemic therapy for an autoimmune or inflammatory disease.
Single group
CD-001
DrugCD-001 administered as an intravenous (lV)infusion.
Adverse events
Adverse events defined as the number of participants with adverse events according
Objective response rate
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Progress-Free Survival
PFS is defined as the time from the administration of the first dose to first disease
Overall Survival
OS is defined as the time from the administration of the first dose to death.
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