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Monoclonal Antibodies

feladilimab (GSK3359609) for Tumors

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 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, GSK3359609, which aims to boost the immune system to fight advanced or recurring cancers. The study focuses on finding the safest and most effective dose, both alone and in combination with other cancer treatments. It targets patients whose cancers have not responded to other therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Parts 1 and 2: Number of participants requiring dose modifications

Parts 1 and 2: Number of participants with any months adverse event(s) (AE) and serious adverse event(s) (SAE)

Parts 1 and 2: Number of participants with clinically significant changes in laboratory parameters and vital signs

+1 more

Secondary study objectives

Part 1 and 2: Number of participants with positive results in GSK3359609

Part 2: AUC(0-tau) of GSK3174998

Part 2: AUC(0-tau) of Pembrolizumab

+23 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Group I: Part 2B: Expansion-feladilimab (GSK3359609)Experimental Treatment2 Interventions

Participants will receive feladilimab (GSK3359609) administered continuously in combination with pembrolizumab.

Group II: Part 2A: Safety run-in (feladilimab (GSK3359609)+chemotherapy)Experimental Treatment6 Interventions

Participants participating in Part 2A chemotherapy combination cohorts will receive feladilimab (GSK3359609) in combination with chemotherapy at doses and schedules based on standard of care practice.

Group III: Part 2A: Dose escalation (feladilimab (GSK3359609)+pembrolizumab)Experimental Treatment2 Interventions

Participants will receive feladilimab (GSK3359609) administered continuously in combination with pembrolizumab.

Group IV: Part 2A: Dose escalation (feladilimab (GSK3359609)+dostarlimab+cobolimab)Experimental Treatment3 Interventions

Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab followed by cobolimab.

Group V: Part 2A: Dose escalation (feladilimab (GSK3359609)+bintrafusp alfa)Experimental Treatment2 Interventions

Participants will receive feladilimab (GSK3359609) administered continuously in combination with bintrafusp alfa.

Group VI: Part 2A: Dose escalation (feladilimab (GSK3359609)+GSK3174998)Experimental Treatment2 Interventions

Participants will receive feladilimab (GSK3359609) administered continuously in combination with GSK3174998.

Group VII: Part 2A: Dose escalation (feladilimab (GSK3359609)+ dostarlimab)Experimental Treatment2 Interventions

Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab.

Group VIII: Part 1B: Expansion feladilimab (GSK3359609)Experimental Treatment1 Intervention

Participants will receive feladilimab (GSK3359609) administered continuously at a dose level chosen for further exploration in dose expansion cohorts.

Group IX: Part 1A: Dose escalation feladilimab (GSK3359609)Experimental Treatment1 Intervention

Participants will receive feladilimab (GSK3359609) administered continuously at a dose level dependent on to which dose level the participant is accrued.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

feladilimab (GSK3359609)

2016

Completed Phase 1

~830

GSK3174998

2015

Completed Phase 1

~1030