SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

The purpose of this study is to assess the safety and efficacy of SKB264 monotherapy in subjects with selected advanced solid tumors.The study is divided into two parts: the Part Ⅰ consists of 4 cohorts, and the Part Ⅱ for expansion. Eligible subjects will receive SKB264 monotherapy, until there is no longer clinical benefit, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Inclusion Criteria:Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;The following histologically or cytologically confirmed tumor types will be enrolled:Part Ⅰ Cohort 1, Cohort 2, Cohort 3, and Part Ⅱ: histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC), locally advanced (stage ⅢB/ⅢC) or metastatic (stage Ⅳ) NSCLC not amenable to radical surgery and/or radical radiotherapy (regardless of concurrent/sequential chemotherapy) ;Part Ⅰ Cohort 4: histologically or cytologically confirmed nonkeratinizing differentiated or undifferentiated nasopharyngeal carcinoma (NPC) with metastatic (stage ⅣB) NPC not amenable to radical local therapy ;Ability to provide fresh or archival tumor tissue for biomarker testing and analysis.At least one measurable target lesion per RECIST 1.1; brain lesions will not considered as target lesions;Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;Expected survival ≥ 12 weeks;Adequate organ and bone marrow function;Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception during the study treatment period and for 6 months after the end of dosing;Subjects who voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol- specified visits and relevant procedures.Exclusion Criteria:For NSCLC, histologically or cytologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components;Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active brain metastases.Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study;History of (noninfectious) interstitial pneumonia (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or suspected ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging;Subjects with HIV test positive or history of AIDS; known active syphilis infection;Pregnant or lactating women;Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 2 weeks prior to the first dose;Requiring strong inhibitors or inducers of CYP3A4 within 2 weeks prior to first dose and during the study (strong inhibitors or inducers of CYP3A4 are not allowed in this study);Live vaccines inoculated within 30 days prior to the first dose or planned to be inoculated during the study.