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 Trial)

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained)

Presence of evaluable disease

The study has specific requirements for reproductive health that participants must meet.

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Exclusion Criteria

Select cardiac abnormalities (as defined in the protocol)

You have cancer that has spread to your brain, spine or brain coverings and require immediate treatment for related symptoms.

You had another type of cancer, except for non-melanoma skin cancer, within the past three years.

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Treatment Details

Interventions

GSK3326595 (Unknown)
Pembrolizumab (Unknown)

Participant Groups

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).