Trials / Unknown
UnknownNCT06075849
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Panolos Bioscience · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Solid Tumor, Adult
- Solid Tumor
- Gastric Cancer
- Hepatocellular Carcinoma
- Metastatic Colorectal Cancer
- Advanced Solid Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-10-25
- Primary completion
- 2024-10-01
- Completion
- 2025-01-01
- First posted
- 2023-10-10
- Last updated
- 2024-02-23
Locations
3 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06075849. Inclusion in this directory is not an endorsement.