The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) combination with Ivonescimab in patients with sq-NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Cancer Vaccine, Intramuscular (IM) injection at escalating dose levels, administered once every 3 weeks (Q3W)
Anti PD 1/VEGF bispecific antibody, administered intravenously at a dose of 200 mg once every 3 weeks
Incidence of dose-limiting toxicity (DLT)
Time frame: 21days since the 1st EVM14 dose
Incidence and severity of TEAE, TRAE, SAEs, and adverse events (AEs) of Grade ≥ 3
Time frame: From first dose until 30±7 days post-last dose
Objective Response Rate(ORR)
Time frame: up to 24 months.
Duration of Response(DOR)
Time frame: up to 24 months.
Disease Control Rate(DCR)
Time frame: up to 24 months.
Progression-Free Survival(PFS)
Time frame: up to 24 months.
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