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.
Single group
LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4)
DrugThe dosage of LNF2105 was increased sequentially from 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.0 mg/kg, 3.0 mg/kg, to 4.5 mg/kg.
To evaluate of Safety and Tolerability of LNF2105 in Patients with Advanced Solid Tumors
Numbers of treatment emergent adverse events with severity determined using NCI CTCAE v6.0 after single or multiple doses of LNF2105.
To confirm Dose Limiting Toxicities (DLT) and determine MTD and RP2D for LNF2105
Occurrence of Dose Limiting Toxicities as defined in the protocol
Maximum observed plasma concentration of LNF2105 (ADC), Total Antibody and Free Payload (Cmax)
Maximum observed plasma concentration ofLNF2105 (ADC), Total Antibody and Free Payload after single and multiple doses
Time to reach Cmax of LNF2105 (ADC), Total Antibody and Free Payload (Tmax)
The amount of time to reach Cmax after single and multiple dose administration of LNF2105 (ADC), Total Antibody and Free Payload
Total Area Under the plasma concentration-time curve of LNF2105 (ADC), Total Antibody and Free Payload (AUC)
Area under the plasma concentration versus time curve after single and multiple dose administration of LNF2105 (ADC), Total Antibody and Free Payload
Minimum Plasma Concentration (Cmin) of LNF2105 (ADC), Total Antibody and Free Payload
Minimum Plasma Concentration (Cmin) of of LNF2105 (ADC), Total Antibody and Free Payload after multiple doses
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