Locally Advanced or Metastatic NSCLCPhase 1NCT03274479
PBF-1129 in Patients With NSCLC
A Phase 1 study testing PBF-1129 in people with Locally Advanced or Metastatic NSCLC, run by Palobiofarma SL at 1 site in United States.
Trial summary
Phase I clinical trial in Eastern Cooperative Oncology Group (ECOG) 0-1 patients with locally advanced or metastatic NSCLC to evaluate safety and tolerability of the compound PBF-1129, an Adenosine A2b receptor antagonist. The phase I dose escalation will be conducted 3+3 method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic NSCLC
- What is being tested?
- PBF-1129
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of metastatic squamous or non-squamous NSCLC.
- Life expectancy greater or equal to 3 months, as determined by the investigator -Patients must have progressed on the standard therapy, including platinum based - chemotherapy. Patients with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations must have progressed on standard treatment options including EGFR, ALK, or ROS-1-directed therapies.
- No limits to the prior lines of treatment
- ECOG performance status of 0/1
- Measurable Disease by RECIST v1.1
- Age greater than 18 years.
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- Adequate bone marrow, renal and hepatic function:
- Absolute neutrophil count (ANC) ≥ 1500 /µL
- White blood cell count (WBC) t ≥ 2.5 x 109/L (2500/µL)
- Lymphocyte count ≥ 0.5 x 109/L (500/µL)
- Platelet count ≥ 100 x 109/L (100,000/µL) without transfusion
- Hemoglobin ≥ (9.0 g/dL) - patients may be transfused to meet this criterion.
- Aspartate aminotransferase AST, alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN)
- Serum bilirubin ≤ 1.5 x ULN, with the exception of patients with known Gilbert disease: serum bilirubin level ≤ 3 x ULN
- Creatinine clearance >60 mL/min (calculated using the Cockcroft-Gault formula) or by 24-hours urine collection
- Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Subject is willing and able to comply with the protocol for the duration of the study
Who cannot join
- Participation in another clinical study with an investigational product during the last 4 weeks or 5 half-lives prior to starting on treatment.
- Symptomatic and/or untreated or actively progressing central nervous system (CNS) metastases or leptomeningeal disease. Patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met:
- The patient has not received stereotactic radiotherapy within 7 days prior to initiation of study treatment or whole-brain radiotherapy within 14 days prior to initiation of study treatment.
- The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anti-convulsant therapy at a stable dose is permitted.
- Serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment.
- Concurrent use of other anticancer approved or investigational agents is not allowed.
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- Autoimmune disorder
- Prior malignancy in past 2 years or as identified in Section 7.2 of this protocol
- Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Patients receiving systemic steroids ≥ 10mg/day of prednisone or the equivalent
- Smoking (cigarettes, cigars or pipes) must be discontinued at least 7 days prior to initiating study drug administration; smoking cessation products (transdermal nicotine patches or chewing gum may be used.
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study. Female subjects must either be of non-reproductive potential or have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of medical Oncology A450B Starling Loving Hall
Ohio City, Ohio, 43210
About this study
Official title: Phase I Trial of PBF-1129 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Phase I clinical trial in Eastern Cooperative Oncology Group (ECOG) 0-1 patients with locally advanced or metastatic NSCLC to evaluate safety and tolerability of the compound PBF-1129, an Adenosine A2b receptor antagonist. The phase I dose escalation will be conducted 3+3 method. Pharmacokinetic (PK) data will be also obtained.
- Conditions
- Locally Advanced or Metastatic NSCLC
- Being tested
- PBF-1129
- Keywords
- adenosine receptors, checkpoint inhibitors, immune system activator
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBF-1129Drug
PBF-1129 once a day by oral administration
| Study group | Role | What they receive |
|---|---|---|
| PBF-1129_40mg | Experimental | Not described Receives: Drug: PBF-1129 |
| PBF-1129_80mg | Experimental | Not described Receives: Drug: PBF-1129 |
| PBF-1129_160mg | Experimental | Not described Receives: Drug: PBF-1129 |
| PBF-1129_320mg | Experimental | Not described Receives: Drug: PBF-1129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of PBF-1129
The MTD evaluation will be based on the Dose-limiting Toxicity (DLT) of the treated Population, which includes all subjects who receive any dose of PBF-1129, and will include Adverse events (AEs), Serious Adverse events (SAEs), laboratory evaluations and electrocardiogram (ECG) results
Measured: 28 days
Secondary outcomes (13)
Time to PBF-1129 peak concentration in plasma "Tmax"
The parameter will be calculated from plasma samples collected at days 1 and 29 after drug administration.It will consist in the time (in minutes) to reach the maximum "PBF-1129" concentration in plasma samples of patients after oral administration of PBF-1129.
Measured: days 1 and 29
Time to PBF-1129 peak concentration in plasma at steady state "Tmax,ss"
The parameter will be calculated from plasma samples collected at days 1 and 29 after drug administration.
It will consist in the time (in minutes) to reach the maximum "PBF-1129" concentration in plasma samples of patients during a dosing interval at steady state.
Measured: days 1 and 29
PBF-1129 peak concentration in plasma "Cmax"
The parameter will be calculated from plasma samples collected at days 1 and 29 after drug administration. It will consist in the maximum plasma concentration (ng/mL) of PBF-1129 observed after administration.
Measured: days 1 and 29
PBF-1129 peak concentration in plasma at steady state"Cmax,ss"
The parameter will be calculated from plasma samples collected at days 1 and 29 after drug administration.It will consist in the maximum plasma concentration (ng/mL) of PBF-1129 observed during a dosing interval at steady state.
Measured: days 1 and 29
The area under PBF-1129 plasma concentration-time curve to infinite time "AUC(0-inf)"
The parameter will be calculated from plasma samples collected at days 1 and 29 after drug administration.
It will consist in the area under the concentration-time curve from zero up to ∞ with extrapolation of the terminal phase. "AUC(0-inf)" will be given in Amount·time/ volume units
Measured: days 1 and 29
The area under PBF-1129 plasma concentration-time curve up to time 't' "AUC(0-t)"
The parameter will be calculated from plasma samples collected at days 1 and 29 after drug administration.It will consist in the area under the concentration-time curve from zero up to a definite time t. "AUC(0-t)" will be given in Amount·time/ volume units.
Measured: days 1 and 29
The area under PBF-1129 plasma concentration-time curve over the dosing interval "AUC(0-τ)"
The parameter will be calculated from plasma samples collected at days 1 and 29 after drug administration. It will consist in the area under the concentration-time curve over the dosing interval. "AUC(0-τ)" will be given in Amount·time/ volume units.
Measured: days 1 and 29
PBF-1129 half-life in plasma " t½"
The parameter will be calculated from plasma samples collected at days 1 and 29 after drug administration. It will consist in the terminal half-life of PBF-1129 in plasma. "t½" will be given in hours (h)
Measured: days 1 and 29
Efficacy as measured by Objective response rate (ORR)
ORR: Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).ORR is defined as confirmed complete response (CR) or partial response (PR) based on modified RECIST v1.1.
Measured: 2 years
Efficacy as measured by Disease control rate (DCR)
The disease control rate (DCR) will be estimated considering the following variables:
Complete response (CR), Partial response (PR) and stable disease (SD) as described by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). These variables will be assessed based on Imaging-based evaluation methods as chest x-ray, conventional computed tomography (CT) and magnetic resonance imaging (MRI) that will be performed every 2 cycles of 28 days administration.
Measured: 2 years
Efficacy as measured by duration of response (DoR)
Duration of response (DoR) is defined as the duration from the first documentation of OR to the first documented disease progression or death due to any cause, whichever occurs first
Measured: 2 years
Efficacy as measured by progression-free survival (PFS)
Progression-free survival (PFS) will be measured from the start of treatment until the documentation of disease progression or death due to any cause, whichever occurs first. For subjects who are alive and progression-free at the time of data cut-off for analysis, PFS will be censored at the last tumor assessment date.
Measured: 2 years
Efficacy as measured by overall survival (OS)
Overall survival (OS) will be determined as the time from the start of treatment until death due to any cause.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Oct 2018
- Primary completion1 May 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced or Metastatic NSCLCStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palobiofarma SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274479
- Sponsor's protocol ID
- PBF-1129CT_03
- Status last verified
- Feb 2024
- First submitted
- 5 Sep 2017
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Owen DH, Wu R, Wei L, Dikov M, Suman S, Su PL, Amann J, Guan S, Spakowicz D, Schweitzer C, Pilcher C, Smith MB, Ferguson S, Palomino JC, Perez SF, Bertino EM, Shields PG, He K, Presley CJ, Otterson GA, Carson WE, Carbone DP. Phase 1 dose escalation trial of the selective adenosine A2B antagonist PBF-1129 in patients with metastatic non-small cell lung cancer. Invest New Drugs. 2025 Dec;43(6):1211-1221. doi: 10.1007/s10637-025-01591-y. Epub 2025 Dec 3.
PubMed 41335275
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of PBF-1129 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03274479
- Acronym / sponsor ID
- PBF-1129CT_03
- Conditions
- Locally Advanced or Metastatic NSCLC
- Keywords
- adenosine receptors, checkpoint inhibitors, immune system activator
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Palobiofarma SLIndustry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 7 Sep 2017 (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.
Phase I clinical trial in Eastern Cooperative Oncology Group (ECOG) 0-1 patients with locally advanced or metastatic NSCLC to evaluate safety and tolerability of the compound PBF-1129, an Adenosine A2b receptor antagonist. The phase I dose escalation will be conducted 3+3 method. Pharmacokinetic (PK) data will be also obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PBF-1129_40mg | Experimental | Drug: PBF-1129 |
| PBF-1129_80mg | Experimental | Drug: PBF-1129 |
| PBF-1129_160mg | Experimental | Drug: PBF-1129 |
| PBF-1129_320mg | Experimental | Drug: PBF-1129 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histological or cytological diagnosis of metastatic squamous or non-squamous NSCLC.
- Life expectancy greater or equal to 3 months, as determined by the investigator -Patients must have progressed on the standard therapy, including platinum based - chemotherapy. Patients with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations must have progressed on standard treatment options including EGFR, ALK, or ROS-1-directed therapies.
- No limits to the prior lines of treatment
- ECOG performance status of 0/1
- Measurable Disease by RECIST v1.1
Key exclusion criteria (12 listed)
- Participation in another clinical study with an investigational product during the last 4 weeks or 5 half-lives prior to starting on treatment.
- Symptomatic and/or untreated or actively progressing central nervous system (CNS) metastases or leptomeningeal disease. Patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met:
- Serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment.
- Concurrent use of other anticancer approved or investigational agents is not allowed.
- Autoimmune disorder
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 |
|---|---|---|
| PBF-1129PBF-1129 once a day by oral administration | Drug | PBF-1129_160mg, PBF-1129_320mg, PBF-1129_40mg, PBF-1129_80mg |
Primary outcome
Maximum Tolerated Dose (MTD) of PBF-1129
Time frame: 28 days
The MTD evaluation will be based on the Dose-limiting Toxicity (DLT) of the treated Population, which includes all subjects who receive any dose of PBF-1129, and will include Adverse events (AEs), Serious Adverse events (SAEs), laboratory evaluations and electrocardiogram (ECG) results
13 secondary outcomes
Time to PBF-1129 peak concentration in plasma "Tmax"
Time frame: days 1 and 29
Time to PBF-1129 peak concentration in plasma at steady state "Tmax,ss"
Time frame: days 1 and 29
PBF-1129 peak concentration in plasma "Cmax"
Time frame: days 1 and 29
PBF-1129 peak concentration in plasma at steady state"Cmax,ss"
Time frame: days 1 and 29
The area under PBF-1129 plasma concentration-time curve to infinite time "AUC(0-inf)"
Time frame: days 1 and 29
The area under PBF-1129 plasma concentration-time curve up to time 't' "AUC(0-t)"
Time frame: days 1 and 29
The area under PBF-1129 plasma concentration-time curve over the dosing interval "AUC(0-τ)"
Time frame: days 1 and 29
PBF-1129 half-life in plasma " t½"
Time frame: days 1 and 29
Efficacy as measured by Objective response rate (ORR)
Time frame: 2 years
Efficacy as measured by Disease control rate (DCR)
Time frame: 2 years
Efficacy as measured by duration of response (DoR)
Time frame: 2 years
Efficacy as measured by progression-free survival (PFS)
Time frame: 2 years
Efficacy as measured by overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 41335275Owen DH, Wu R, Wei L, Dikov M, Suman S, Su PL, Amann J, Guan S, Spakowicz D, Schweitzer C, Pilcher C, Smith MB, Ferguson S, Palomino JC, Perez SF, Bertino EM, Shields PG, He K, Presley CJ, Otterson GA, Carson WE, Carbone DP. Phase 1 dose escalation trial of the selective adenosine A2B antagonist PBF-1129 in patients with metastatic non-small cell lung cancer. Invest New Drugs. 2025 Dec;43(6):1211-1221. doi: 10.1007/s10637-025-01591-y. Epub 2025 Dec 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBF-1129 in people with Locally Advanced or Metastatic NSCLC, run by Palobiofarma SL at 1 site in United States.
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 17 inclusion and 12 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 9 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 1 site in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of PBF-1129 (time frame: 28 days). 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 NCT03274479, which also lists 1 linked publication.
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 9 Feb 2024.