PBF-1129 for Non-Small Cell Lung Cancer

Overseen By Nahomi Castro Palomino, Ph.D

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Palobiofarma SL

Must not be taking: Corticosteroids, Anticancer agents

Disqualifiers: CNS metastases, Autoimmune disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 28 days

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called PBF-1129 to see if it is safe and tolerable for patients with advanced or spreading lung cancer who are in relatively good health. The drug works by blocking a receptor that may help cancer grow.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use other anticancer drugs or investigational agents while participating. If you are on systemic steroids or smoking, there are specific restrictions.

What data supports the effectiveness of the drug PBF-1129 for treating non-small cell lung cancer?

Research shows that blocking the A2B adenosine receptor, which PBF-1129 targets, can help fight cancer by reducing tumor growth and improving the immune system's ability to attack cancer cells. This approach has shown promise in preclinical studies and early clinical trials for various cancers, including lung cancer. ^{1 2 3 4 5}

Is PBF-1129 safe for humans?

PBF-1129, an A2B adenosine receptor antagonist, was evaluated for safety in a phase I clinical trial with patients having non-small cell lung cancer, indicating it has been tested in humans for safety. ^{1 2 3 4 5}

What makes the drug PBF-1129 unique for treating non-small cell lung cancer?

PBF-1129 is unique because it targets the A2B adenosine receptor, which is involved in regulating the tumor environment and immune response, making it different from traditional chemotherapy or targeted therapies that do not focus on this receptor. ^{1 2 3 6 7}

Eligibility Criteria

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.

Inclusion Criteria

You have a disease that can be measured using a specific set of guidelines.

Life expectancy greater or equal to 3 months, as determined by the investigator

My lung cancer is confirmed to be metastatic through testing.

Exclusion Criteria

Concurrent use of other anticancer approved or investigational agents is not allowed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PBF-1129 in a dose-escalation study to evaluate safety and tolerability

28 days

Visits on days 1 and 29 for pharmacokinetic sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Regular imaging every 2 cycles of 28 days

Treatment Details

Interventions

• PBF-1129

Trial Overview 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.

Participant Groups

Group I: PBF-1129_80mg Experimental Treatment 1 Intervention

Group II: PBF-1129_40mg Experimental Treatment 1 Intervention

Group III: PBF-1129_320mg Experimental Treatment 1 Intervention

Group IV: PBF-1129_160mg Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Palobiofarma SL

Lead Sponsor

Trials

10

Recruited

560+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Improving combination therapies: targeting A2B-adenosine receptor to modulate metabolic tumor microenvironment and immunosuppression. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Discovery of LAS101057: A Potent, Selective, and Orally Efficacious A2B Adenosine Receptor Antagonist. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Novel non-xanthine antagonist of the A2B adenosine receptor: From HTS hit to lead structure. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Adenosine Receptor Antagonists to Combat Cancer and to Boost Anti-Cancer Chemotherapy and Immunotherapy. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A2B adenosine receptor blockade inhibits growth of prostate cancer cells. [2021]

6. Greece pubmed.ncbi.nlm.nih.gov

The A3 adenosine receptor agonist CF102 induces apoptosis of hepatocellular carcinoma via de-regulation of the Wnt and NF-kappaB signal transduction pathways. [2013]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a Radiofluorinated Adenosine A2B Receptor Antagonist as Potential Ligand for PET Imaging. [2021]