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

Part of paid clinical trials in Denver, Colorado.

Sponsor
GlaxoSmithKline
Study ID
NCT02783300
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GSK3326595 — DRUG
    GSK3326595 will be administered with and without food, in tablet and capsule formulation.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered.

Study Details

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 Dates

Start date
Aug 30, 2016
Status verified
Feb 2025
Primary completion
Aug 30, 2023
Completion
Aug 30, 2023

Study Design

Enrollment
297 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 30 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteDenverColorado80218-
GSK Investigational SiteMiamiFlorida33136-
GSK Investigational SiteNew YorkNew York10065-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteDallasTexas75230-
GSK Investigational SiteSan AntonioTexas78229-

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By research site
GSK Investigational Site· Denver, COGSK Investigational Site· Miami, FLGSK Investigational Site· New York, NYGSK Investigational Site· Nashville, TNGSK Investigational Site· Dallas, TXGSK Investigational Site· San Antonio, TX

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