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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called PBF-1129, an adenosine A2B receptor antagonist, for individuals with non-small cell lung cancer (NSCLC) that has advanced or metastasized. The main goal is to determine if PBF-1129 is safe and tolerable for participants. Researchers will test different doses to identify the optimal one. Individuals with NSCLC who have undergone previous treatments and continue to experience the disease might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that PBF-1129 is generally safe for people with non-small cell lung cancer. In studies, patients did not experience serious side effects that would prevent doctors from increasing the dose. This suggests the treatment is safe at the doses tested. However, since PBF-1129 remains in the early testing stages, its safety continues to be closely monitored. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PBF-1129 for non-small cell lung cancer because it targets the A2B adenosine receptor, which is a novel approach compared to standard treatments like chemotherapy and immunotherapy. Unlike these existing options, which often have broad effects, PBF-1129 aims to specifically disrupt cancer cell signaling pathways linked to tumor growth and immune suppression. This targeted mechanism could potentially lead to more effective treatments with fewer side effects, making it a promising option for patients.

What evidence suggests that PBF-1129 might be an effective treatment for non-small cell lung cancer?

Research has shown that PBF-1129, a new drug, may help treat non-small cell lung cancer (NSCLC). In earlier studies, patients tolerated the drug well and did not experience serious side effects. Importantly, PBF-1129 effectively targeted and blocked certain pathways that cancer cells use to grow. These early results suggest that PBF-1129 could be a promising treatment option for patients with advanced NSCLC. Participants in this trial will receive different dosages of PBF-1129 to further evaluate its effectiveness and safety. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/732/755124/Abstract-732-Targeting-adenosine-A2B-receptor

Targeting adenosine A2B receptor using PBF-1129 in treating ... Abstract 732: Targeting adenosine A2B receptor using PBF-1129 in treating patients with metastatic non-small cell lung cancer Available.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37195421/

targeting A2B-adenosine receptor to modulate metabolic ... In patients with non-small cell lung cancer, PBF-1129 was well tolerated, with no dose-limiting toxicities; demonstrated pharmacologic efficacy; ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05234307

Study Details | NCT05234307 | PBF-1129 and Nivolumab ... This phase I trial studies the side effects and best dose of PBF-1129 in combination with nivolumab in treating patients with non-small cell lung cancer ...

4. academic.oup.com academic.oup.com/jnci/article/115/11/1404/7169112

targeting A2B-adenosine receptor to modulate metabolic ... In patients with non-small cell lung cancer, PBF-1129 was well tolerated, with no dose-limiting toxicities; demonstrated pharmacologic efficacy; modulated the ...

5. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT03274479/

Clinical Trial: NCT03274479 ... NSCLC to evaluate safety and tolerability of the compound PBF-1129, an Adenosine A2b receptor antagonist. The phase I dose escalation will ...

6. jitc.bmj.com jitc.bmj.com/content/10/Suppl_2/A612

585 Phase 1 dose escalation trial of the selective A2B ... We conducted a phase 1 dose escalation trial of PBF-1129, a first in class selective A2BAR inhibitor in patients with mNSCLC who progressed on chemotherapy and ...