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Immunomodulating Agents

A total of 6 cohorts are planned, and each dose escalation will proceed in a traditional 3+3 scheme.

Cohorts of 3-6 patients receive PB101 until the MTD is determined. The dose (2 mg/kg-15 mg/kg) assigned to the cohort will be administered weekly for two 28-day cycles or until progressive disease (PD), unacceptable toxicity, withdrawal of subject consent, and/or the investigator's decision to discontinue the study treatment occurs.

Administration may be continued for subjects in whom PB101 provides clinical benefits at the discretion of the investigator.

PB101

Jin A Shin, PhD

Hong Jae Chon, MD/PhD

Keun Wook Lee, MD/PhD

Myoung-An Lee, MD/PhD

Myung-Ah Lee, MD/PhD

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.

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.

Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent

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

For each time point by dose group, number of subjects, mean, standard deviation, and median, minimum, and maximum values will be presented for continuous variables, and frequency and percentage will be presented for categorical variables.

Serum vascular endothelial growth factor (VEGF) - A, placental growth factor (PlGF), and VEGF receptor 1 (VEGFR1) measurements by dose group and visit

Frequency and percentage by dose group due to adverse drug reactions (ADR)

Incidence by dose group for treatment-emergent adverse events (TEAEs), ADRs, serious adverse events (SAEs), and serious ADRs

Clinically significant changes in ECG results compared to baseline

Multigated blood pool scan (MUGA) or echocardiography (ECHO), clinical significance and significant changes evaluated

Frequency according to response evaluation criteria in solid tumors (RECIST) v1.1

Tumor response will be evaluated according to RECIST v1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent	NCT06075849	Solid Tumor, Ad... Solid Tumor Gastric Cancer Hepatocellular ... Metastatic Colo... Advanced Solid ...	PB101	19 Years -	Panolos Bioscience
Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent	NCT06075849	Solid Tumor, Ad... Solid Tumor Gastric Cancer Hepatocellular ... Metastatic Colo... Advanced Solid ...	PB101	19 Years -	Panolos Bioscience

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