The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid tumors to determine the recommended Phase II dose (RP2D), and the secondary objective is to evaluate the PK and PD characteristics, immunogenicity and preliminary clinical efficacy of RC148. Phase II will primarily evaluate the efficacy of the RC148 combination regimen, and secondarily will assess safety and tolerability, PK characteristics, and immunogenicity. During the trial, investigators will also evaluate the potential correlation of biomarkers with efficacy.
Be able to participate in the study voluntarily and willing to provide written informed consent.
male or female ≥18 years (phase Ⅰ), 18 to 75 years old (Including 18 and 75 years, phase Ⅱ).
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Projected life expectancy of at least 12 weeks.
Pregnant or lactating.
Cohort 1 in Phase II, patients with histologically or cytologically confirmed non-small cell lung cancer, other than squamous lung cancer and lung adenocarcinoma, (including subjects with squamous or adenocarcinoma in combination with other pathologic types of non-small cell lung cancer;) prior treatment with docetaxel, or an antitumor agent that targets VEGF/VEGFR; and treatment with at least 2 cycles of an immune checkpoint inhibitor, with a best response of PD, or best response of CR/PR/SD with disease progression within 6 months of first dose.
Cohorts 4-7 in Phase II, patients with ocular corneal conditions at screening such as congenital corneal dystrophy, meibomian gland dysfunction (MGD), viral keratitis (dendritic, map-like, corneal stromal keratitis), uveitis, corneal endothelial decompensation, glaucoma, iridocorneal endothelial syndrome (ICE).
Subjects with active hepatitis B or C; human immunodeficiency virus (HIV)-positive subjects.
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Treatment groupsSee each treatment group below.