This study is a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor efficacy of LNF2105 in patients with advanced solid tumors.
Male or female aged ≥18 years.
Patients with advanced solid tumors (including but not limited to urothelial carcinoma, breast cancer, non-small cell lung cancer, ovarian cancer, endometrial cancer, and cervical cancer) that have been histologically or cytologically confirmed as having failed/cannot tolerate/have no standard treatment/are currently unsuitable for standard treatment.
Able to provide previous Nectin-4 expression testing results or preserved/fresh tumor tissue for Nectin-4 expression testing.
At least one measurable lesion (CT or MRI long axis ≥ 10 mm, lymph node short axis ≥ 15 mm) according to RECIST v1.1 criteria. For lesions previously treated with radiotherapy, they will only be included as measurable lesions if there has been clear disease progression after radiotherapy.
Prior treatment with an antibody-drug conjugate (ADC) exhibiting one of the following characteristics: payload as a topoisomerase I inhibitor (TOP 1 inhibitor); antibody target as Nectin-4.
Received any P-glycoprotein (P-gp) inducer/inhibitor, strong CYP3A inhibitor, or breast cancer resistance protein (BCRP) inhibitor within 14 days prior to first administration (see Appendix 3 for the exclusion list).
Patients who received chemotherapy within 3 weeks or radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks prior to first administration of the study drug, excluding the following.
Patients who received systemic glucocorticoid therapy or any other form of immunosuppressive therapy (equivalent to a prednisone dose >10 mg/day) within 2 weeks prior to the first dose.