GSK3745417 for Cancer

Recruiting at 11 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must not be taking: Immunosuppressants, Checkpoint inhibitors

Disqualifiers: Autoimmune, Liver disease, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

97 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, GSK3745417, alone and with another drug, dostarlimab, in patients whose solid tumors have not responded to other treatments or have returned. The goal is to find the best dose and see if these drugs can help shrink the tumors. Dostarlimab is recently approved for the treatment of various cancers, including certain types of endometrial cancer.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Adults with advanced solid tumors that have worsened or not responded to existing treatments can join this trial. They must be at least 18, have a confirmed diagnosis, measurable disease, good organ function, and an ECOG performance status of 0-1. Women who can bear children need to use effective contraception and cannot be pregnant or breastfeeding.

Inclusion Criteria

I am 18 years old or older.

I am fully active or can carry out light work.

My organs are functioning well.

Exclusion Criteria

I have had vasculitis in the past.

I haven't taken any immune checkpoint inhibitors in the last 28 days.

I have had symptoms of pericarditis in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive GSK3745417 alone or with dostarlimab to evaluate safety, tolerability, and establish a recommended dose

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GSK3745417

Trial Overview The study is testing GSK3745417 alone (Part 1A) or combined with dostarlimab (Part 2A) in patients with stubborn solid tumors. It's in the first phase where they're figuring out safe doses and checking how well it works by gradually increasing the dose.

Participant Groups

Group I: Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort Experimental Treatment 2 Interventions

Group II: Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School