Clinical Study of CVL006 Combination With 9MW2821

Age: 18-75 years old (inclusive), no restriction on gender.

Patients with histologically or cytologically confirmed advanced solid tumors. Cohort A: Squamous cell carcinoma of the head and neck; the primary tumor must arise from the oral cavity, oropharynx, hypopharynx or larynx, excluding nasopharyngeal tumors, salivary gland tumors and/or parotid gland tumors.

For Phase Ib participants: Advanced solid tumors with failure of prior standard therapy. For Phase II part, Cohort A: Recurrent or metastatic disease not curable by local therapy. Participants must have no prior systemic therapy, unless the prior systemic therapy was completed more than 6 months ago as adjuvant or neoadjuvant treatment. Participants who received prior PD-1/PD-L1 inhibitors in curative therapy are eligible if at least 12 months have elapsed since the last dose of anti-PD-L1 agent. Cohort B: No prior systemic therapy for locally advanced or metastatic disease. For patients who received adjuvant/neoadjuvant therapy or curative chemoradiotherapy, disease progression within 6 months after the last treatment is regarded as first-line setting.

For Phase II: PD-L1 Combined Positive Score (CPS) ≥ 1 confirmed by local or central immunohistochemistry (IHC). If no PD-L1 testing result is available, participants shall submit archived or fresh tumor tissue samples during screening for central laboratory testing of programmed death ligand-1 (PD-L1) and Nectin4. The central PD-L1 testing result must be obtained prior to enrollment. Participants with known PD-L1 results confirming CPS ≥ 1 shall submit archived or fresh tissue samples for exploratory analysis within 5 days after enrollment.