Phase I Study of LNF1901 in Advanced Malignant Tumors
ConditionAdvanced Malignant Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong New Time Pharmaceutical Co., LTD
About this trial
This is a multicenter, open, phase I dose-escalation and dose-expansion study to evaluate the safety, tolerability, initial antitumor efficacy, PK and immunogenic characteristics of LNF1901 in patients with advanced malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female ≥18 years of age;
Patients with advanced malignant tumors who have been confirmed histologically or cytologically and have failed to receive standard therapy, or cannot tolerate standard therapy, or cannot receive standard therapy for other reasons;
Participants enrolled in the dose expansion phase had at least one measurable lesion; (4) Those who adopted the United States Eastern Oncology Consortium (ECOG) physical status score of 0~1;
Disqualifiers
Those who have previously received antibody treatment with any tumor necrosis factor receptor (TNFR) superfamily agonists, such as CD40, OX40, CD137, CD27, CD357, etc.;
Those who have received anti-tumor therapy 4 weeks before the first administration or within 5 half-lives of the drug (whichever is shorter);
Chronic systemic glucocorticoid therapy within 2 weeks prior to initial administration (daily dose equivalent to prednisone > 10mg of systemic corticosteroids) or any other form of immunosuppressive therapy;
The toxicity of previous anti-tumor therapy has not returned to CTCAE5.0 version of the definition ≤ Class 1 (except hair loss);
Trial design
Design model
Single group
Treatments tested in this trial
LNF1901 Monoclonal Antibody Injection
DrugLNF1901，7 dose groups:0.003mg/kg、0.03mg/kg、0.1mg/kg、0.3mg/kg、1mg/kg、2mg/kg、3mg/kg，IV, infusion time 60min±10min, Q3W, until disease progression or other reasons to stop treatment, the longest administration to 2 years, whichever occurs first.
Treatment groups
82 Participants
are divided into 1 treatment groupGroup A: LNF1901 monotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose limiting toxicities
DLTs will include Grade 4 neutropenia, anemia, thrombocytopenia, Grade 4 cytokine release syndrome and other Grade 3 non-hematological toxicity etc
Time frame
Up to 21 days following first dose of APX005M2
Incidence of adverse events
Incidence and severity of AEs and specific laboratory abnormalities graded according to NCI-CTCAE, v5.0
Time frame
Through up to approximately 30 days following last dose of LNF1901Locations
Sponsors and contacts
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Shandong New Time Pharmaceutical Co., LTD
Lead sponsor
Sun Yat-sen University
Collaborator
Source ClinicalTrials.gov
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