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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

Study Summary

This trial is investigating the safety and effectiveness of the drug GSK3359609 as a treatment for various types of cancer. The study will be conducted in two parts, with each part having two phases. The primary objective is to determine the safety and tolerability of the drug.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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
Gemcitabine plus Carboplatin
2016
Completed Phase 1
~830
Docetaxel
1995
Completed Phase 4
~5620
GSK3174998
2015
Completed Phase 1
~1030
Dostarlimab
2020
Completed Phase 2
~1000
Pemetrexed
2014
Completed Phase 3
~5250
Pembrolizumab
2017
Completed Phase 2
~2010
Bintrafusp alfa
2020
Completed Phase 2
~1110
Paclitaxel plus Carboplatin
2016
Completed Phase 1
~830
Fluorouracil (5-FU) plus carboplatin or cisplatin
2016
Completed Phase 1
~830
Cobolimab
2016
Completed Phase 1
~830

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,753 Previous Clinical Trials
8,068,629 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,175 Total Patients Enrolled
11 Trials studying Tumors
2,324 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,101 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.

To what extent do potential risks arise when utilizing feladilimab (GSK3359609)?

"Our team at Power have assigned a score of 1 to feladilimab (GSK3359609), due to the limited clinical research regarding its efficacy and safety. This is a phase one trial, so there are only preliminary results available."

Answered by AI

How many individuals are currently enrolled in this research trial?

"No longer actively recruiting, this medical trial was first posted on June 23rd 2016 and had its latest edit on December 1st 2022. If you are looking for similar studies, there are currently 2,380 active cancer trials as well as 2,828 that involve feladilimab (GSK3359609)."

Answered by AI

What beneficial results are expected from this research?

"This clinical trial has a two-fold aim: to observe any clinically relevant alterations in vital signs and laboratory parameters, as well as monitor the concentrations of Pembrolizumab and ADA test results for GSK3359609 paired with either pembrolizumab or GSK3174998. The duration of observation is 28 days."

Answered by AI

Are enrollments still open for this investigation?

"Reports on clinicaltrials.gov render this trial inactive in terms of recruitment, with its last update occuring on December 1st 20202 since its posting date from June 23rd 2016. Nevertheless, there are a plethora of other medical trials actively registering patients at the moment - 5208 to be exact."

Answered by AI

For what situations is feladilimab (GSK3359609) commonly prescribed?

"feladilimab (GSK3359609) is a widely prescribed intervention for malignant melanoma of skin, as well as recurrent cervical cancer, refractory or relapsed mediastinal large B-cell lymphoma and initial treatment."

Answered by AI

How many venues are currently offering this clinical trial?

"At the moment, 8 clinical trial sites are enrolling patients. These locations include Duarte, Los Angeles and New york, as well as 5 other cities. To minimise travel requirements for participants it is advised to select a site that is closest in proximity."

Answered by AI

Have there been any other experiments conducted involving feladilimab (GSK3359609)?

"Since 1997, GSK3359609 (feladilimab) has been subject to 3956 completed clinical trials. Currently, 2828 of these studies are in progress across the world but primarily out of Duarte California where City of Hope Comprehensive Cancer Center is based."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)
2016. "Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02723955.
~95 spots leftby Apr 2025
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