A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
GlaxoSmithKline
Study ID
NCT03843359
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • GSK3745417 — DRUG
    GSK3745417 will be administered.
  • Dostarlimab — DRUG
    Dostarlimab will be administered.

Study Details

This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.

Key Dates

Start date
Mar 12, 2019
Status verified
Dec 2025
Primary completion
Apr 4, 2024
Completion
Mar 31, 2026

Study Design

Enrollment
97 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort
  • Experimental: Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort

Primary Outcome Measure

Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W) [ Time Frame: Up to 21 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteHoustonTexas77030-

Find similar trials in Houston, TX

By research site
GSK Investigational Site· Houston, TX

Related Studies