PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Dwight Owen
Study ID
NCT05234307
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Lung Non-Small Cell Carcinoma
  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adenosine A2B Receptor Antagonist PBF-1129 — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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 that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as PBF-1129 and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

First listed
Feb 10, 2022
Start date
Nov 21, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (PBF-1129, nivolumab)
    Patients receive PBF-1129 PO QD and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 30 days after the last dose of study treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Dwight H. Owen, MD, MS, FACP
[email protected]
614-293-6786
Catherine Schweitzer
[email protected]
614-685-5414
Dwight H. Owen, MD, MS, FACP (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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