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Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

NCT06075849•Panolos Bioscience

View on ClinicalTrials.gov

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

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥19 years of age
•2. 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.
•3. Patient who has at least one measurable or non-measurable but evaluable lesion that meets the RECIST version 1.1.
•4. Patient whose expected survival period is 12 weeks or longer.
•5. Patient with eastern cooperative oncology group (ECOG) performance status ≤ 2
•6. 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.)
•7. 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.
•* When receiving warfarin, patient whose INR is ≤3.0 There must be no active bleeding (bleeding within 14 days) or pathological conditions with a high risk of bleeding (e.g., tumor with macrovesicular invasion or known varicose vein).
+1 more criteria

Exclusion Criteria

•Patients who meet any of the following criteria cannot participate in this clinical trial.
•1. Patient expected to show hypersensitivity to the active ingredient and components of PB101 or similar drugs.
•2. 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.
+33 more criteria

Locations (3)

CHA University Bundang Medical Center

Seongnam, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Key Dates

Start Date

October 25, 2023

Primary Completion Date

October 1, 2024

Completion Date

January 1, 2025

Last Updated

February 23, 2024

Enrollment

ESTIMATED participants

Conditions

Solid Tumor, AdultSolid TumorGastric CancerHepatocellular CarcinomaMetastatic Colorectal CancerAdvanced Solid Tumor

Interventions

PB101

DRUG

Contacts

Jin A Shin, PhD

CONTACT

+82)31-8055-0886 jashin@panolos.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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