A non-randomized, open-ended, phase I dose-escalation and dose-expansion study was designed to evaluate the safety, tolerability, antitumor efficacy, PK and immunogenic characteristics of LNF2007 in patients with advanced solid tumors
Age ≥18 years old, gender unlimited;
United States Eastern Oncology Consortium (ECOG) physical strength score 0-1;
Expected survival ≥12 weeks;
Patients with advanced solid tumors confirmed histologically or cytologically (gastric cancer, pancreatic cancer, and cholangiocarcinoma are preferred) who have failed after adequate standard treatment, or who lack standard treatment options (standard treatment is defined as the standard treatment guidelines that have been agreed in the country (if applicable) or the standard treatment status in the country); Standard treatment failure is defined as disease progression or tumor recurrence or metastasis during or after treatment, or intolerance);
Received any antitumor therapy within 4 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever is shorter);
Had undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the trial drug, or required elective surgery during the trial;
Received systemic corticosteroid (systemic corticosteroid equivalent to prednisone >10mg daily) or other immunosuppressive therapy within 2 weeks prior to the first use of the experimental drug;
Prior to first administration of the investigational drug, all reversible adverse effects of previous antitumor therapy did not return to CTCAE v5.0 rating ≤1, excluding alopecia (any grade) and ≤2 peripheral sensory neuropathy or other toxicities deemed by the investigators to be of no safety risk;
Single group
LNF2007
DrugLNF2007，9 dose groups:0.2μg/kg、1μg/kg、5μg/kg、20μg/kg、60μg/kg、120μg/kg、240μg/kg、360μg/kg、540μg/kg（0.2\~5μg/kg for "accelerated titration", and i3+3 ramp-up starting from 20μg/kg dose group），IV, infusion time 60min±10min, Q4W, until disease progression 、intolerable toxicity or other reasons to stop treatment, the longest administration to 2 years, whichever occurs first.
The incidence of LNF2007 treatment-emergent adverse events
Incidence and severity of AEs and specific laboratory abnormalities graded according to NCI-CTCAE, v5.0
Occurrence of dose-limiting toxicity (DLT)
DLTs will include Grade 4 neutropenia, anemia, thrombocytopenia, ≥ Grade 3 Febrile neutropenia ，Grade 5 toxicity and other Grade 3 non-hematological toxicity etc
The maximum tolerated dose and/or the recommended phase II dose of LNF2007
Dose Finding
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