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Adenosine A2b receptor antagonist
PBF-1129 for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by Palobiofarma SL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological diagnosis of metastatic squamous or non-squamous NSCLC
ECOG performance status of 0/1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new compound to treat lung cancer. The goal is to find out if it is safe and how well it works.
Who is the study for?
This trial is for adults over 18 with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have tried standard treatments, including chemotherapy and targeted therapies if they have certain mutations. They should be in good physical condition (ECOG 0/1), not on high-dose steroids, free of autoimmune diseases, and not pregnant. Smokers must quit at least a week before starting the study.Check my eligibility
What is being tested?
The trial tests PBF-1129, a new drug targeting Adenosine A2b receptors, to see how safe it is and what effects it has on NSCLC patients. It's an early-phase study where doses are gradually increased following the '3+3 method' to find the right balance between safety and effectiveness.See study design
What are the potential side effects?
While specific side effects of PBF-1129 aren't listed as this is a Phase I trial primarily assessing safety, potential risks may include typical reactions to cancer drugs such as nausea, fatigue, liver issues or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to be metastatic through testing.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had multiple treatments for my condition.
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My cancer has worsened despite standard treatments, including those for specific mutations.
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I am older than 18 years.
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My kidney, liver, and bone marrow are functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of PBF-1129
Secondary outcome measures
Efficacy as measured by Disease control rate (DCR)
Efficacy as measured by Objective response rate (ORR)
Efficacy as measured by duration of response (DoR)
+10 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: PBF-1129_80mgExperimental Treatment1 Intervention
Group II: PBF-1129_40mgExperimental Treatment1 Intervention
Group III: PBF-1129_320mgExperimental Treatment1 Intervention
Group IV: PBF-1129_160mgExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Palobiofarma SLLead Sponsor
9 Previous Clinical Trials
469 Total Patients Enrolled
Ohio State UniversityOTHER
824 Previous Clinical Trials
501,545 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious illnesses or infections that would stop me from receiving the study treatment.I have brain metastases that are either treated and stable or untreated and not worsening.You have a disease that can be measured using a specific set of guidelines.My lung cancer is confirmed to be metastatic through testing.I have an autoimmune disorder.I am taking 10mg or more of prednisone daily or its equivalent.I stopped smoking at least a week ago.I am fully active or restricted in physically strenuous activity but can do light work.I have had multiple treatments for my condition.My cancer has worsened despite standard treatments, including those for specific mutations.I am older than 18 years.I have not had an autoimmune disease in the past 2 years, except for vitiligo, Grave's disease, or psoriasis not needing systemic treatment.My kidney, liver, and bone marrow are functioning well.I have not had any other cancer in the past 2 years.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
Research Study Groups:
This trial has the following groups:- Group 1: PBF-1129_80mg
- Group 2: PBF-1129_160mg
- Group 3: PBF-1129_320mg
- Group 4: PBF-1129_40mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the application process for this research project still open?
"The clinical trial is recruiting, as evidenced by the data hosted on clinicaltrials.gov; it was first posted on October 1st 2018 and has since been updated twice - most recently done in February 22nd 2022."
Answered by AI
Can you shed some light on the potential risks of PBF-1129?
"PBF-1129's safety rating is pegged at 1, as this is an early stage clinical trial with little evidence of the drug's efficacy and limited data on its safety."
Answered by AI
What is the upper limit for enrollees in this investigation?
"Affirmative. According to information sourced from clinicaltrials.gov, this medical study is actively recruiting participants; it was initially posted on October 1st 2018 and the latest update occurred on February 22nd 2022. The trial requires 18 volunteers that can be found in a single location."
Answered by AI
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