An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma

Completed · Phase 1

Conditions studied: Neoplasms

In brief

This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).

Key facts

Study ID

NCT02783300

Run by

GlaxoSmithKline

People needed

297

Starts

2016-08-30

Expected to finish

2023-08-30

Last updated by the study team

2025-03-10

Who can join

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

You may qualify if…

• Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained)
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2
• Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL
• Presence of evaluable disease
• Adequate organ function (as defined in the protocol)
• Reproductive criteria (as defined in the protocol).

You may not qualify if…

• Malignancy attributed to prior solid organ transplant
• Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example [e.g.], for symptomatic disease)
• History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years
• Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
• Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
• Select cardiac abnormalities (as defined in the protocol)
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
• History of optic nerve neuropathy or neuritis.

Where it is running

• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Edmonton, Alberta, Canada
• GSK Investigational Site — Ottawa, Ontario, Canada
• GSK Investigational Site — Toronto, Ontario, Canada
• GSK Investigational Site — Bordeaux, France
• GSK Investigational Site — Lyon, France
• GSK Investigational Site — Villejuif, France
• GSK Investigational Site — Amsterdam, Netherlands
• GSK Investigational Site — Leiden, Netherlands
• GSK Investigational Site — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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