Safety, Tolerability, PK, and Efficacy of CD-001 in Advanced Head & Neck Cancers

Inclusion criteria

• 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.
• Expected survival ≥ 3 months.

Exclusion criteria

• 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.
• Patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing.
• At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk.
• Patients with a history of ≥ Grade 3 (CTCAE) immune-related adverse events (irAEs) during prior anti-tumor therapy or permanent drug discontinuation due to irAEs.
• Patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.