Ppc China Corp. Ltd.

The primary objective is to evaluate the efficacy of Imsidolimab compared to placebo in subjects with acute flares of GPP. The secondary objective is to evaluate the safety of Imsidolimab in subjects with acute flares of GPP. The exploratory objectives are to explore the effect of Imsidolimab on biomarkers; explore GPP-related mutations and other pharmacogenomic analyses; evaluate the PK of Imsidolimab in subjects with acute flares of GPP; evaluate the immunogenicity of Imsidolimab; and evaluate the effect of Imsidolimab on plaque psoriasis in subjects with concurrent plaque psoriasis at baseline.

The primary objective of Part A (dose escalation portion) of this study is to determine the safety and tolerability (including DLT) of oral administration of KIN-3248 in subjects with advanced tumors harboring FGFR2 and/or FGFR3 genetic alterations (including fusions) and to determine the maximum tolerated dose (MTD) and/or RP2D of KIN-3248 for further clinical development. The primary objective of Part B (dose expansion portion) of the study is to evaluate preliminary evidence of antitumor activity of KIN-3248 in subjects with advanced tumors harboring FGFR2 and/or FGFR3 genetic alterations. Secondary objectives are to characterize the PK of KIN-3248. Exploratory objectives include additional characterization of exposure-effect relationships for efficacy and safety and potential KIN-3248 metabolites; evaluation of the target modulation effects of KIN-3248, and evaluation of potential biomarkers of response/resistance to KIN-3248 treatment in blood samples and/or tumor biopsies.

Primary Objective To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on improvement of IDFS in the study population. Secondary Objectives The secondary objectives of the study are: 1. To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on the following aspects in the study population: a. Overall survival (OS) b. Quality of life (QoL) c. Breast cancer free interval (BCFI) d. Distant metastasis free interval (DDFS) 2. To determine the safety and tolerability of adagloxad simolenin (OBI-822)/OBI-821 in the study population. Exploratory objectives The exploratory objectives are as follows: 1. To explore the correlation between adagloxad simolenin (OBI-822)/OBI-821 anti-Globo H antibody response, IDFS, and OS 2. To evaluate the impact of Globo H tumor expression on IDFS and OS 3. To identify patient baseline and demographic characteristics that may predict adagloxad simolenin (OBI-822)/OBI-821 treatment outcomes 4. To explore the correlation between baseline characteristics (including tumor pathology, molecular and immune characteristics) and tumor expression levels