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

NCT06075849 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PB101

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.

Sponsors & Collaborators

  • Panolos Bioscience

    lead INDUSTRY

Principal Investigators

  • Hong Jae Chon, MD/PhD · CHA University Bundang Medical Center

  • Keun Wook Lee, MD/PhD · Seoul National University Bundang Hospital

  • Myung-Ah Lee, MD/PhD · The Catholic University of Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2024-10-31
Completion
2025-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06075849 on ClinicalTrials.gov