A Study of JSKN027 in Patients With Advanced Solid Tumors
brief summary
This is a first-in-human, open-label, multicenter Phase 1 (Ia/Ib) clinical study conducted in China to evaluate the safety and tolerability of JSKN027 in patients with advanced malignant solid tumors. The study will also assess the pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of JSKN027, and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D). The study includes two parts. Part Ia is a dose-escalation phase designed to evaluate the safety and tolerability of increasing dose levels of JSKN027. Part Ib is a dose-expansion phase in which additional patients will be enrolled at selected dose levels to further evaluate safety and preliminary antitumor activity in specific tumor types. Initial expansion cohorts are planned for patients with colorectal cancer, non-small cell lung cancer, and hepatocellular carcinoma.
detailed description
This is a first-in-human, open-label, multicenter Phase 1 (Ia/Ib) clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of JSKN027 in patients with advanced malignant solid tumors, and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D).
The study consists of two parts: a dose-escalation phase (Part Ia) and a dose-expansion phase (Part Ib). In Part Ia, an accelerated titration design followed by an i3+3 dose-escalation design will be used to evaluate multiple dose levels of JSKN027 and assess its safety and tolerability. In Part Ib, multiple expansion cohorts will be enrolled based on tumor type to further evaluate the safety and preliminary efficacy of JSKN027 at selected dose levels. Initial expansion cohorts are planned for patients with colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and hepatocellular carcinoma (HCC).
official title
A First-in-Human, Open-Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of JSKN027 in Patients With Advanced Malignant Solid Tumors