Spots Global Cancer Trial Database for Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent
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Trial Identification
Brief Title: Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent
Official Title: A Multicenter, Open-label, Dose Escalation and Expansion, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PB101 in Patients With Advanced Solid Tumor
Study ID: NCT06075849
Interventions
Study Description
Brief Summary: This clinical trial is designed as a multi-center, open-label, dose-escalation, dose-expansion, phase 1 clinical trial and will be evaluating the safety and efficacy of PB101 in patients with advanced solid tumors who have progressed after standard of care. PB101 may stop the growth of tumor cells by blocking blood flow to the tumor and modulating the tumor microenvironment.
Detailed Description: Primary Objectives To assess the safety and tolerability of PB101 and determine the maximum tolerated dose (MTD) and/or the recommended phase-2 dose Secondary Objectives 1. To characterize the pharmacokinetics of PB101. 2. To identify the preliminary anti-tumor activity of PB101. 3. To assess the immunogenicity of PB101. Tertiary Objectives To explore the correlation between potential pharmacodynamic (PD) biomarkers (e.g., vascular endothelial growth factor(VEGF)-A, placental growth factor (PlGF) and VEGFR1 signaling) and anti-cancer activity of PB101.
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHA University Bundang Medical Center, Seongnam, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Hong Jae Chon, MD/PhD
Affiliation: CHA University Bundang Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Keun Wook Lee, MD/PhD
Affiliation: Seoul National University Bundang Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Myung-Ah Lee, MD/PhD
Affiliation: The Catholic University of Korea
Role: PRINCIPAL_INVESTIGATOR
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