← Back to Search

Unknown

GSK3326595 for Tumors (Meteor 1 Trial)

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

Meteor 1 Trial Summary

This trial will assess the safety and preliminary clinical activity of GSK3326595 in people with advanced or recurrent solid tumors, or non-Hodgkin's lymphoma.

Eligible Conditions
  • Tumors

Meteor 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of participants with dose limiting toxicities (DLTs)
Part 2: GBM cohort: Six-month progression free survival (PFS) rate
Part 2: Participants with NHL: ORR based on Lugano criteria
+3 more
Secondary outcome measures
Heart rate
Part 2: (Participants in ACC tablet cohort): Duration of Response (DOR)
Part 2: (Participants in ACC tablet cohort): Overall survival (OS)
+13 more

Meteor 1 Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3: GSK3326595 in combination with pembrolizumabExperimental Treatment2 Interventions
Participants with selected solid tumors will be administered GSK3326595 in combination with pembrolizumab as part of this dose determination study.
Group II: Part 2: Disease-Specific Expansion cohortExperimental Treatment1 Intervention
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.
Group III: Part 1: Dose Escalation, Food effect and Relative Bioavailability of Capsule formulation to TabletExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
GSK3326595
2016
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,067,164 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,642 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the aims of this research endeavor?

"This trial aims to assess the change of laboratory parameters, vital signs, physical examination and organ-specific characteristics over a period no longer than 21 days. Other objectives of this study include evaluating participants' accumulation ratio (AR) of GSK3326595 using blood samples collected at certain intervals as well as progression-free survival (PFS) and overall survival (OS)."

Answered by AI

Is enrollment for this clinical investigation ongoing?

"The trial in question has ceased, for the time being, to accept new candidates; it was first posted on August 30th 2016 and last updated on June 23rd 2022. However, there are still 4945 trials actively recruiting individuals."

Answered by AI

What is the participant count for this research endeavor?

"This study is no longer admitting patients. Originally posted on August 30th, 2016 and last updated June 23rd of 2022, it has completed its recruitment phase. However, if you seek other studies there are 3982 trials recruiting cancer-related participants and 963 clinical trials currently seeking individuals for GSK3326595 research."

Answered by AI

In what applications is GSK3326595 typically employed?

"GSK3326595 is commonly prescribed to manage malignant neoplasms, though it can also be used to treat unresectable melanoma, microsatellite instability high, and patients who have experienced relapse post-chemotherapy."

Answered by AI

Are there several medical centers that have implemented this clinical experiment in the city?

"Currently, 11 clinical trial sites are accepting patient recruitment. These include Miami, New york and Middletown as well as other cities that may be more conveniently located for potential patients. Therefore, it is beneficial to seek out the nearest site in order to reduce travel requirements if you decide to participate."

Answered by AI

Is GSK3326595 sanctioned by the FDA?

"GSK3326595's safety profile is rated as a 1, due to the limited evidence of its efficacy and lack of collected data regarding its potential side effects."

Answered by AI

Are there any documented cases of GSK3326595 being tested for therapeutic purposes?

"Currently, there are 963 active investigations looking into GSK3326595 with 122 of them in their third phase. The majority of these medical trials take place in Houston, Texas; however, it is also being administered at 35772 locations worldwide."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2016. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02783300.
~34 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top