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

Panolos Bioscience3 sites in 1 country30 target enrollmentOctober 25, 2023

ConditionsSolid Tumor, Adult Solid Tumor Gastric Cancer Hepatocellular Carcinoma Metastatic Colorectal Cancer Advanced Solid Tumor

InterventionsPB101

DrugsPB101

Overview

Phase: Phase 1
Intervention: PB101
Conditions: Solid Tumor, Adult
Sponsor: Panolos Bioscience
Enrollment: 30
Locations: 3
Primary Endpoint: Dose limiting toxicity (DLT)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 25, 2023

End Date

January 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Panolos Bioscience

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following inclusion criteria.
•≥19 years of age
•Patients with unresectable locally advanced or metastatic solid tumor, confirmed histologically and cytologically, who is refractory to existing standard of care or has progressive disease and has no other available standard of care available.
•Patient who has at least one measurable or non-measurable but evaluable lesion that meets the RECIST version 1.
•Patient whose expected survival period is 12 weeks or longer.
•Patient with eastern cooperative oncology group (ECOG) performance status ≤ 2
•Patient whose adequate hematological function, and kidney and liver functions have been confirmed by the following criteria. (Laboratory tests are allowed to re-conducted within the screening period.)
•Patient with adequate anticoagulant functions according to the following criteria:
•Without receiving anticoagulant therapy, patient whose international normalized ratio (INR) is ≤ 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT) is ≤ 5 seconds above the ULN.
•When receiving an oral anticoagulant or low molecular weight heparin, patient whose prothrombin time (PT) or PTT is confirmed to be stable for at least 2 weeks.

Exclusion Criteria

•Patients who meet any of the following criteria cannot participate in this clinical trial.
•Patient expected to show hypersensitivity to the active ingredient and components of PB101 or similar drugs.
•Patient with the following medical history (including surgery/procedure history) confirmed.
•Major surgery within 4 weeks prior to administration of the IP, and clinically significant traumatism.
•Cardiovascular disease (including unstable angina, myocardial infarction, stroke, and transient ischemic attack), congestive heart failure (NYHA class III or IV), or clinically significant arrhythmia uncontrollable by medication within 24 weeks prior to administration of the IP.
•Patient whose left ventricular ejection fraction (LVEF) measured by echocardiography, multigated blood pool scan (MUGA) scan or the standard procedure at the institution before administration of the IP is less than the lower limit of normal at the institution. However, if there is no reference LVEF set at the institution, 50% will be treated as the reference level.
•Vascular disorders (e.g., deep vein thrombosis, pulmonary embolism, aortic aneurysm, and peripheral arterial thrombosis) within 24 weeks prior to administration of the IP
•Life-threatening (Grade 4) venous thromboembolism (regardless of the duration, even if it is a past medical history)
•Medical history of primary malignancies other than indication for this clinical trial. However, the following cases are allowed:
•Not less than 3 years have passed since the cure diagnosis of a primary malignancy. However, in case of papillary thyroid cancer, patients who underwent curative resection can participate in the study regardless of the duration.