Solid Tumor, AdultPhase 1NCT06075849
Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent
A Phase 1 study testing PB101 in people with Solid Tumor, Adult and Solid Tumor, run by Panolos Bioscience at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor, Adult, Solid Tumor, Gastric Cancer
- What is being tested?
- PB101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 25 Oct 2023to Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 1.1.
- Patient whose expected survival period is 12 weeks or longer.
- Patient with eastern cooperative oncology group (ECOG) performance status ≤ 2
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- 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.
- 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).
- Patient who voluntarily gave informed consent in writing to participate in this clinical trial after being provided with information on the nature and risks of the study as well as the expected desirable benefits and AEs of the investigative product (IP).
Who cannot join
- 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.
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- 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.
- At least 1 year has passed since complete resection of cutaneous basal cell carcinoma/squamous cell carcinoma of the skin or successful treatment of cervical carcinoma in situ.
- Psychiatric disorder that may significantly affect the participation in the study at the discretion of the investigator.
- Patient with the following comorbidities confirmed at the time of participation in the study.
- Squamous cell carcinoma of the lung (current and past medical history).
- Interstitial lung disease or pulmonary fibrosis (current and past medical history).
- The following hemorrhage-related and digestive system diseases (current and past medical history).
- Evidence of active bleeding, hemorrhagic diathesis, coagulopathy, and tumor with macrovesicular invasion.
- Clinically significant medical history of digestive system, such as peptic ulcer, gastrointestinal bleeding, gastrointestinal or non-gastrointestinal fistulas or perforations, intra-abdominal abscesses, clinical symptoms and signs of gastrointestinal obstruction, and inflammatory bowel disease.
- Clinically significant pericardial effusion, pleural fluid, or ascites. However, in case of ascites, patients who do not require paracentesis for improvement of the symptoms can participate in the study.
- Uncontrolled hypertension (systolic blood pressure (SBP) > 150 or diastolic blood pressure (DBP) > 90 mmHg even after medication).
- Infection of active hepatitis B* or C† virus
- Hepatitis B surface antigen (HBsAg)-positive at screening. However, for HBsAg positive, not excluded if the patient is taking antiviral agents stably.
- †Hepatitis C virus antibody (HCV Ab)-positive at screening. However, if the result of HCV RNA test is negative, participation is possible.
- Human immunodeficiency virus (HIV)-positive.
- Severe infection or other uncontrolled active infection that requires administration of systemic antibiotics, antivirals, etc. at the discretion of the investigator
- New or active brain metastases. However, patients who do not need central nervous system (CNS) treatment immediately (or within 1 cycle) at the discretion of the investigator can participate in the study.
- Leptomeningeal metastasis
- Serious and unhealed wound or fracture
- Patient who received the following treatment regimens (drug/non-drug)
- patient who received the following anti-cancer treatments other than this IP.
- Chemotherapy, hormone therapy, and radiation therapy within 2 weeks prior to administration of the IP. However, patients who completed local radiotherapy as a palliative therapy for the purpose of pain relief in areas other than the target lesion (e.g., site of bone metastases) and recovered from following acute toxicity (e.g., myelosuppression).However, patients who completed local radiotherapy as a palliative therapy for the purpose of pain relief in areas other than the target lesion (e.g., site of bone metastases) and recovered from following acute toxicity (e.g., myelosuppression).However, patients who completed local radiotherapy as a palliative therapy for the purpose of pain relief in areas other than the target lesion (e.g., site of bone metastases) and recovered from following acute toxicity (e.g., myelosuppression).
- Targeted therapies or immunotherapy within 4 weeks prior to administration of the IP.
- Administration history of nitrosoureas or mitomycin-C within 6 weeks prior to administration of the IP.
- Administration history of nonsteroidal anti-inflammatory drugs (NSAID) and anti-platelet agents within 7 days prior to administration of the IP. However, for aspirin, doses of 325 mg/day are allowed.
- Patient who participated in another clinical study within 4 weeks prior to administration of the IP and received (underwent procedure of) an investigational drug (or medical device).
- Patient who continues to experience a clinically significant toxicity or adverse event of Grade 2 or higher (based on NCI-CTCAE v5.0) after prior anti-cancer therapy. However, hair loss (any grade) and neuropathy (Grade 2 or lower) are exceptions.
- Pregnancy test positive at screening, or pregnant or lactating woman.
- Female or male subject of childbearing potential who does not agree to stay abstinent or use an effective method of contraception† during the study period and for at least 26 weeks (women) or 14 weeks (men) after the last dose of the IP.
- †Effective method of contraception:
- Hormonal contraceptive: Subdermal implants, injections, oral contraceptives, etc. However, in case of ovarian/breast cancer, hormonal contraception is not allowed.
- Implantation of an intrauterine device or intrauterine system: Loop, and hormone-containing intrauterine system.
- Sterilization procedure or surgery of the subject or his/her spouse (partner): Vasectomy, tubal ligation, etc.
- Other patients deemed ineligible to participate in the study by the investigator.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
CHA University Bundang Medical Center
Seongnam
Hong Jae Chon, MD/PhD, +82)31-780-5000, hongjaechon@gmail.com
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Keun Wook Lee, MD/PhD, +82)2-1588-3369, imdoctor@snu.ac.kr
- Not yet recruiting
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
Myoung-An Lee, MD/PhD, +82)2-1588-1511, angelamd@catholic.ac.kr
About this study
Official title: 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
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.
Read the 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
- To characterize the pharmacokinetics of PB101.
- To identify the preliminary anti-tumor activity of PB101.
- 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
- Being tested
- PB101
- Keywords
- Neoplasms, Angiogenesis Inhibitors, Antineoplastic Agents, Angiogenesis Modulating Agents, Immuno Modulating Agents
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Hepatocellular, Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PB101Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| PB101 | Experimental | A total of 6 cohorts are planned, and each dose escalation will proceed in a traditional 3+3 scheme. Receives: Drug: PB101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Frequency by dose group
Measured: 8 weeks
Permanent discontinuation / dose reduction due to adverse events (AE)
Frequency and percentage by dose group due to adverse drug reactions (ADR)
Measured: 8 weeks
Adverse events
Incidence by dose group for treatment-emergent adverse events (TEAEs), ADRs, serious adverse events (SAEs), and serious ADRs
Measured: 8 weeks
Electrocardiogram (ECG)
Clinically significant changes in ECG results compared to baseline
Measured: 8 weeks
Left ventricular ejection fraction (LVEF)
Multigated blood pool scan (MUGA) or echocardiography (ECHO), clinical significance and significant changes evaluated
Measured: 8 weeks
Secondary outcomes (7)
Objective response rate (ORR)
Frequency according to response evaluation criteria in solid tumors (RECIST) v1.1
Measured: 8 weeks
Duration of response (DOR)
Time analyzed using Kaplan-Meier method
Measured: 8 weeks
Progression free survival (PFS)
Time analyzed using Kaplan-Meier method
Measured: 8 weeks
Disease control rate (DCR)
Time analyzed using Kaplan-Meier method
Measured: 8 weeks
Time to progression (TTP)
Time analyzed using Kaplan-Meier method
Measured: 8 weeks
Overall survival (OS)
Time analyzed using Kaplan-Meier method
Measured: 8 weeks
Tumor Evaluations
Tumor response will be evaluated according to RECIST v1.1
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start25 Oct 2023
- Primary completionOct 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panolos Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Jae Chon, MD/PhD, Principal investigator, CHA University Bundang Medical CenterKeun Wook Lee, MD/PhD, Principal investigator, Seoul National University Bundang HospitalMyung-Ah Lee, MD/PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075849
- Sponsor's protocol ID
- PB101_101
- Status last verified
- Feb 2024
- First submitted
- 25 Sep 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JE, Kim C, Yang H, Park I, Oh N, Hua S, Jeong H, An HJ, Kim SC, Lee GM, Koh GY, Kim HM. Novel glycosylated VEGF decoy receptor fusion protein, VEGF-Grab, efficiently suppresses tumor angiogenesis and progression. Mol Cancer Ther. 2015 Feb;14(2):470-9. doi: 10.1158/1535-7163.MCT-14-0968-T. Epub 2014 Dec 22.
PubMed 25534360Go EJ, Yang H, Lee SJ, Yang HG, Shin JA, Lee WS, Lim HS, Chon HJ, Kim C. PB101, a VEGF- and PlGF-targeting decoy protein, enhances antitumor immunity and suppresses tumor progression and metastasis. Oncoimmunology. 2023 Sep 20;12(1):2259212. doi: 10.1080/2162402X.2023.2259212. eCollection 2023.
PubMed 37744990
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06075849
- Acronym / sponsor ID
- PB101_101
- Conditions
- Solid Tumor, Adult, Solid Tumor, Gastric Cancer, Hepatocellular Carcinoma, Metastatic Colorectal Cancer, Advanced Solid Tumor
- Keywords
- Neoplasms, Angiogenesis Inhibitors, Antineoplastic Agents, Angiogenesis Modulating Agents, Immuno Modulating Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Panolos BioscienceIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To characterize the pharmacokinetics of PB101.
- To identify the preliminary anti-tumor activity of PB101.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PB101 | Experimental | Drug: PB101A total of 6 cohorts are planned, and each dose escalation will proceed in a traditional 3+3 scheme. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 1.1.
- Patient whose expected survival period is 12 weeks or longer.
Key exclusion criteria (43 listed)
- 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.
- Patient with the following comorbidities confirmed at the time of participation in the study.
- Hepatitis B surface antigen (HBsAg)-positive at screening. However, for HBsAg positive, not excluded if the patient is taking antiviral agents stably.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PB101Cohorts 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. | Drug | PB101 |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 8 weeks
Frequency by dose group
Permanent discontinuation / dose reduction due to adverse events (AE)
Time frame: 8 weeks
Frequency and percentage by dose group due to adverse drug reactions (ADR)
Adverse events
Time frame: 8 weeks
Incidence by dose group for treatment-emergent adverse events (TEAEs), ADRs, serious adverse events (SAEs), and serious ADRs
Electrocardiogram (ECG)
Time frame: 8 weeks
Clinically significant changes in ECG results compared to baseline
Left ventricular ejection fraction (LVEF)
Time frame: 8 weeks
Multigated blood pool scan (MUGA) or echocardiography (ECHO), clinical significance and significant changes evaluated
7 secondary outcomes
Objective response rate (ORR)
Time frame: 8 weeks
Duration of response (DOR)
Time frame: 8 weeks
Progression free survival (PFS)
Time frame: 8 weeks
Disease control rate (DCR)
Time frame: 8 weeks
Time to progression (TTP)
Time frame: 8 weeks
Overall survival (OS)
Time frame: 8 weeks
Tumor Evaluations
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 25534360Lee JE, Kim C, Yang H, Park I, Oh N, Hua S, Jeong H, An HJ, Kim SC, Lee GM, Koh GY, Kim HM. Novel glycosylated VEGF decoy receptor fusion protein, VEGF-Grab, efficiently suppresses tumor angiogenesis and progression. Mol Cancer Ther. 2015 Feb;14(2):470-9. doi: 10.1158/1535-7163.MCT-14-0968-T. Epub 2014 Dec 22.
- Background: PubMed 37744990Go EJ, Yang H, Lee SJ, Yang HG, Shin JA, Lee WS, Lim HS, Chon HJ, Kim C. PB101, a VEGF- and PlGF-targeting decoy protein, enhances antitumor immunity and suppresses tumor progression and metastasis. Oncoimmunology. 2023 Sep 20;12(1):2259212. doi: 10.1080/2162402X.2023.2259212. eCollection 2023.
- Company linkLink provided by the sponsor.
- Mechanism of ActionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Jae Chon, MD/PhD principal investigator
CHA University Bundang Medical Center
Keun Wook Lee, MD/PhD principal investigator
Seoul National University Bundang Hospital
Myung-Ah Lee, MD/PhD principal investigator
The Catholic University of Korea
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PB101 in people with Solid Tumor, Adult and Solid Tumor, run by Panolos Bioscience at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin A Shin, PhD (+82)31-8055-0886, jashin@panolos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06075849, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.