A Phase Ib Trial of PBF-1129 and Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer

Who is this study for? Patients with advanced non-small cell lung cancer
What treatments are being studied? PBF-1129+Nivolumab
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological, Procedure
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>= 18 years

• Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology without curative options

• Measurable disease based on RECIST 1.1

• Patients must have received standard of care chemotherapy and immunotherapy. No limits to prior lines of therapy. Prior PD-1 and/or PD-L1 directed therapies are required. Prior CTLA4 therapy is permitted. Patients may have received no more than 3 prior lines of therapy in the metastatic setting (excluding targeted therapies)

• Patients with known actionable mutations with Food and Drug Administration (FDA)-approved treatment options must have received all approved and standard of care treatment options (ie osimertinib for EGFR, alectinib for ALK, etc)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Absolute neutrophil count (ANC) \>= 1,500 /mcL

• Platelets \>= 100,000 / mcL

• Serum creatinine OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) =\< 1.5 X upper limit of normal (ULN) OR \>= 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN

• Serum total bilirubin =\< 1.5 X ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN

• AAspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 X ULN OR =\< 5 X ULN for subjects with liver metastases

• Albumin \>= 2.5 mg/dL

• International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

• Anticipated life expectancy of \>= 3 months

• Willing to comply with study procedures

• Must be able to swallow pills

• Female subjects of childbearing potential must be willing to use an adequate method of contraception

• For female patients of childbearing potential, a negative serum pregnancy test within 7 days prior to first dose of protocol therapy is required

• Be willing and able to understand and sign the written informed consent document

• Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. A recently obtained archival FFPE tumor tissue block (if an FFPE tissue block cannot be provided, 15 unstained slides (10 minimum) will be acceptable) from a primary or metastatic tumor resection or biopsy can be provided if it was obtained within 1 year of trial screening. Patients with archival tissue that does not meet this criteria may still be eligible in the dose escalation cohort only upon approval from PI.

• For patients in dose expansion cohort: Be willing to provide tissue from a pre-treatment and on-treatment fin needle aspirate (FNA) or core biopsy of a tumor lesion. Subjects must consent to pre-treatment and on-treatment biopsy prior to initiation of clinical trial, however subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may still continue on study

• Be willing to provide peripheral blood samples for correlative studies

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Contact Information
Primary
The Ohio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
800-293-5066
Time Frame
Start Date: 2022-11-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Leads: Dwight Owen
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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