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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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02783300
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 GlaxoSmithKline
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 GSK Clinical Trials
Principal Investigator Affiliation GlaxoSmithKline
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries Canada, France, Netherlands, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Neoplasms
Arms & Interventions

Arms

Experimental: Part 1: Dose Escalation, Food effect and Relative Bioavailability of Capsule formulation to Tablet

Participants will receive escalating doses of GSK3326595 until the maximum tolerated dose level is reached. The recommended phase 2 dose (RP2D) will be determined. Participants will be dosed in a fed (high-fat, high-calorie meal) and fasted state to determine the effect of food on bioavailability of GSK3326595, and will be dosed with tablet and capsule to compare two formulations of GSK3326595 (capsule versus tablet).

Experimental: Part 2: Disease-Specific Expansion cohort

Participants with triple-negative breast cancer (TNBC), metastatic transitional cell carcinoma of the urinary system (mTCC), Grade IV anaplastic astrocytoma (glioblastoma multiforme [GBM]), non-Hodgkin's lymphoma (NHL), adenoid cystic carcinoma (ACC), hormone receptor-positive adenocarcinoma of the breast (ER+BC), human papillomavirus (HPV)-positive solid tumors of any histology, and p53-wild type non-small cell lung cancer (NSCLC) will be administered GSK3326595 at the recommended phase 2 dose (RP2D) as determined in Part 1.

Experimental: Part 3: GSK3326595 in combination with pembrolizumab

Participants with selected solid tumors will be administered GSK3326595 in combination with pembrolizumab as part of this dose determination study.

Interventions

Drug: - GSK3326595

GSK3326595 will be administered with and without food, in tablet and capsule formulation.

Drug: - Pembrolizumab

Pembrolizumab will be administered.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

GSK Investigational Site, Denver, Colorado

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Address

GSK Investigational Site

Denver, Colorado, 80218

GSK Investigational Site, Miami, Florida

Status

Address

GSK Investigational Site

Miami, Florida, 33136

GSK Investigational Site, Middletown, New Jersey

Status

Address

GSK Investigational Site

Middletown, New Jersey, 07748

GSK Investigational Site, Harrison, New York

Status

Address

GSK Investigational Site

Harrison, New York, 10604

GSK Investigational Site, New York, New York

Status

Address

GSK Investigational Site

New York, New York, 10065

GSK Investigational Site, Nashville, Tennessee

Status

Address

GSK Investigational Site

Nashville, Tennessee, 37203

GSK Investigational Site, Dallas, Texas

Status

Address

GSK Investigational Site

Dallas, Texas, 75230

GSK Investigational Site, San Antonio, Texas

Status

Address

GSK Investigational Site

San Antonio, Texas, 78229

International Sites

GSK Investigational Site, Edmonton, Alberta, Canada

Status

Address

GSK Investigational Site

Edmonton, Alberta, T6G 1Z2

GSK Investigational Site, Ottawa, Ontario, Canada

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Address

GSK Investigational Site

Ottawa, Ontario, K1H 8L6

GSK Investigational Site, Toronto, Ontario, Canada

Status

Address

GSK Investigational Site

Toronto, Ontario, M5G 1Z5

GSK Investigational Site, Bordeaux Cedex, France

Status

Address

GSK Investigational Site

Bordeaux Cedex, , 33076

GSK Investigational Site, Lyon Cedex 08, France

Status

Address

GSK Investigational Site

Lyon Cedex 08, , 69373

GSK Investigational Site, Villejuif cedex, France

Status

Address

GSK Investigational Site

Villejuif cedex, , 94805

GSK Investigational Site, Amsterdam, Netherlands

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Address

GSK Investigational Site

Amsterdam, , 1066 CX

GSK Investigational Site, Leiden, Netherlands

Status

Address

GSK Investigational Site

Leiden, , 2333 ZA

GSK Investigational Site, Rotterdam, Netherlands

Status

Address

GSK Investigational Site

Rotterdam, , 3015 GD

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