What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy often results in side effects such as neutropenia, febrile neutropenia, nausea, fatigue, and increased liver function tests. Immunotherapy, including agents like pembrolizumab and atezolizumab, can cause immune-related adverse events such as rash, stomatitis, and hemoptysis. Targeted therapies, depending on the specific agent, may lead to side effects like hypertension and increased liver function tests. For treatments similar to PBF-1129, specific side effects are not detailed, but general side effects of targeted therapies can include gastrointestinal disturbances and fatigue.

What prior FDA approvals exist?

FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy and chemotherapy combinations such as pembrolizumab with chemotherapy and atezolizumab with bevacizumab and chemotherapy. Additionally, fam-trastuzumab deruxtecan is approved for HER2-mutant NSCLC. These treatments have shown efficacy in various clinical trials and are used for advanced stages of the disease. There is no specific mention of FDA-approved Adenosine A2b receptor antagonists like PBF-1129 in the provided context.

What other types of research exist?

Promising novel alternatives to PBF-1129 for NSCLC patients include BIBF 1120 (nintedanib), which has shown promising efficacy and a favorable safety profile in Phase II trials, and furmonertinib, which has demonstrated efficacy and an acceptable safety profile in a Phase III study for EGFR mutation-positive NSCLC.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) of PBF-1129

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and traditional chemotherapies. Targeted therapies, such as EGFR inhibitors (e.g., osimertinib) and ALK inhibitors (e.g., crizotinib), work by specifically targeting and inhibiting the activity of mutated proteins that drive cancer cell growth. Immunotherapies, like PD-1/PD-L1 inhibitors (e.g., pembrolizumab), enhance the body's immune response against cancer cells by blocking proteins that suppress immune activity. Traditional chemotherapies, such as cisplatin, kill rapidly dividing cells, including cancer cells, by damaging their DNA. These treatments are crucial for NSCLC patients as they offer personalized and effective options based on the genetic profile of the tumor. Treatments like PBF-1129, an Adenosine A2b receptor antagonist, represent a novel approach by targeting specific pathways involved in tumor growth and immune evasion, potentially offering new avenues for therapy in NSCLC.

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