A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Solid Tumor, Pancreatic Adenocarcinoma

In brief

A first-in-human open-label, Phase I/II study to evaluate the safety, tolerability, MTD/RP2D, PK, and preliminary efficacy of OBI-3424 administered as a single agent.

Key facts

Study ID

NCT03592264

Run by

OBI Pharma, Inc

People needed

68

Starts

2018-07-02

Expected to finish

2024-03-21

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior radiotherapy to more than 25% of the bone marrow
• Symptomatic brain metastases, unless previously treated and well controlled for at least 4 weeks after central nervous system (CNS)-directed treatment as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the Screening Period. Patients with known leptomeningeal disease are excluded.
• Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the current study
• Patients with hepatocellular carcinoma (applies to Expansion Phase only)
• Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 3 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C)
• Concomitant use of strong CYP3A4 inhibitors/inducers
• Concomitant use of naproxen within a 48-hour window before and after OBI-3424 dosing
• Females who are pregnant or breast-feeding
• Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
• Unwillingness or inability to comply with the study protocol for any reason

Where it is running

• Scripps Clinic Torrey Pines — La Jolla, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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