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 (Meteor 1)

  • STATUS
    Recruiting
  • End date
    Apr 29, 2025
  • participants needed
    322
  • sponsor
    GlaxoSmithKline
Updated on 26 January 2022
lymphoma
estrogen
measurable disease
carcinoma
fasting
tumor growth
growth factor
bilateral oophorectomy
BRAF
TP53
pembrolizumab
HER2
EGFR
pd-l1
primary cancer
neuropathy
solid tumor
targeted therapy
solid neoplasm

Summary

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).

Details
Condition Neoplasms
Treatment Pembrolizumab, GSK3326595 Capsules, GSK3326595, GSK3326595.
Clinical Study IdentifierNCT02783300
SponsorGlaxoSmithKline
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
Select cardiac abnormalities (as defined in the protocol)
History of optic nerve neuropathy or neuritis
Malignancy attributed to prior solid organ transplant
Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels
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
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