Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

EOS884448 and iberdomide will be administered

EOS884448, iberdomide and dexamethasone will be administered

EOS884448 will be administered in arm A,B and C

EOS884448

Iberdomide will be administered in arm B and C

Iberdomide

Dexamethasone will be administered in arm C

Iteos Clinical Trials

This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).

Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

Study of EOS884448 Alone, and in Combination With Iberdomide With or Without Dexamethasone, in Participants With Relapsed or Refractory Multiple Myeloma

Bristol-Myers Squibb

GlaxoSmithKline

iTeos Therapeutics

iTeos Belgium SA

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Analgesics

Docetaxel

Ipilimumab

Dostarlimab

Interleukin-2

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Feladilimab

GSK4428859A/EOS884448 will be administered.

GSK4428859A

GSK6097608

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Centre

Ani Balmanoukian

Balazs Halmos

Davey B Daniel

David R Spigel

Quincy Chu

Parneet Cheema

Adrian Sacher

Sophie Cousin

Nicolas Girard

Gerard Zalcman

David Planchard

Martin Reck

Angelo Delmonte

Manolo D'Arcangelo

Giuseppe Lo Russo

Michele Maio

Enriqueta Felip

Pilar Garrido López

Laura Medina Rodríguez

GSK Clinical Trials

This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC. Drug name mentioned as GSK4428859A (belrestotug) and EOS884448 are interchangeable for the same compound and will be referred to as GSK4428859A/EOS884448/belrestotug.

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)

A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

IPD for this study will be made available via the Clinical Study Data Request site.

Overall survival will be calculated as time from randomization to death.

Objective response rate will be calculated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. It is defined as the percentage of participants with a best overall confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria.

DCR is defined as the percentage of participants with a best overall confirmed CR, PR or stable disease (SD) at any time as per disease-specific criteria.

Milestone survival rate of participants treated with experimental regimens versus SoC therapy.

CR, PR, SD and PD will be evaluated as per RECIST version 1.1 criteria.

PFS is defined as time from the date of randomization to the date of disease progression or death whichever occurs earlier.

ORR is defined as the percentage of participants with a confirmed CR or PR at any time per RECIST version 1.1 criteria.

DOR is defined as the first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria.

DCR is defined as the percentage of participants with a best overall confirmed CR, PR or SD at any time as per disease-specific criteria.

Number of participants with iCR, iPR, iUPD, iCPD and iSD per modified RECIST 1.1 for immune-based therapeutics (iRECIST) criteria.

iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria.

iORR is defined as the percentage of participants with a confirmed CR or PR at any time per iRECIST criteria.

iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria.

Symptoms and General Pathology

Death

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pembrolizumab

Immunomodulating Agents

Participants will be administered an intravenous (IV) infusion of pembrolizumab as monotherapy in a fixed dose.

Participants will be administered an IV infusion of dostarlimab as monotherapy in a fixed dose.

Participants will be administered an IV infusion of dostarlimab in a fixed dose followed by an IV infusion of belrestotug in a fixed dose (Dose A).

Participants will be administered an IV infusion of dostarlimab in a fixed dose followed by an IV infusion of belrestotug in a fixed dose (Dose B).

Participants will be administered an IV infusion of dostarlimab in a fixed dose followed by an IV infusion of belrestotug in a fixed dose (Dose C).

Participants will be administered an IV infusion of dostarlimab in a fixed dose followed by an IV infusion of belrestotug along with IV infusion of GSK6097608 in a fixed dose.

Pembrolizumab will be administered as an IV infusion.

Dostarlimab will be administered as an IV infusion.

Belrestotug will be administered as an IV infusion.

Belrestotug

GSK6097608 will be administered as an IV infusion.

Lasika Seneviratne

Harshad V Amin

Vishal Jindal

Umit Tapan

Atul Kumar

Paul B Gilman

Mohammed Almubarak

Aldo Agustín Perfetti

Enrique Fermin Aman

Christian Sebastián Fuentes

Gustavo Alberto Lopez

Omar Esteban Carranza

Luciano Piazzoni

Jose Nicolas Minatta

Geronimo Rosselli

Juan Manuel Puig

Lucas Pratta

Reinier R Wener

Glaucio Antonio Bertollo

Ana Caroline Zimmer Gelatti

Gustavo Pinto

William Nassib William Jr

Gilberto de Castro Junior

Jussi Koivunen

Jarkko Ahvonen

Maria Silvoniemi

Antti Jekunen

Youssef Oulkhouir

Philippe Rochigneux

Romain Corre

Céline Mascaux

Michael Thomas

Martin Schuler

Martin Wermke

Tobias Rachow

Christian Grohe

Konstantinos Syrigos

Flora Zagouri

Amanda Psyrri

Athanasios Kotsakis

Konstantinos Papazisis

George Fountzilas

Sofia Baka

Theodoros Kontakiotis

Krisztina Bogos

Zsolt Kiraly

Laszlo Urban

Csaba Böcskei

Gabriella Galffy

Cesare Gridelli

Federico Cappuzzo

Carlo Genova

Lorenzo Livi

Giacomo Allegrini

Paolo Piacentini

Chiara Matilde Catania

Tetsuya Sakai

Isamu Okamoto

Miyako Satouchi

Terufumi Kato

Hidetoshi Hayashi

Kyoichi Kaira

Hee Kyung Ahn

Dong-Wan Kim

Byoung Chul Cho

Dae Ho Lee

Byoung Yong Shim

Angel Gomez-Villanueva

Juan-Carlos Vazquez-Limon

Jessica Gricelda Reyes-Contreras

Emanuel Citgez

John W.G. van Putten

Wouter Van Geffen

Elisabeth A Lisanne Kastelijn

Izabela Chmielewska

Anna Lowczak

Marta Czeluscinska-Murawiec

Krzysztof Rogoziewicz

Pedro Brito

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma	NCT05289492	Multiple Myelom...	EOS884448 Iberdomide Dexamethasone	18 Years -	iTeos Therapeutics
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)	NCT03739710	Neoplasms	Docetaxel Feladilimab Ipilimumab GSK4428859A Dostarlimab GSK6097608	18 Years -	GlaxoSmithKline
A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer	NCT05565378	Lung Cancer, No...	Pembrolizumab Dostarlimab Belrestotug GSK6097608	18 Years -	GlaxoSmithKline
Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors	NCT04446351	Neoplasms	GSK6097608 Dostarlimab Cobolimab Belrestotug	18 Years -	GlaxoSmithKline
First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors	NCT05277051	Neoplasms	GSK4381562 Dostarlimab GSK4428859A	18 Years -	GlaxoSmithKline
Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma	NCT05289492	Multiple Myelom...	EOS884448 Iberdomide Dexamethasone	18 Years -	iTeos Therapeutics
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)	NCT03739710	Neoplasms	Docetaxel Feladilimab Ipilimumab GSK4428859A Dostarlimab GSK6097608	18 Years -	GlaxoSmithKline
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	NCT05060432	Advanced Cancer Lung Cancer Head and Neck C... Melanoma	EOS-448 pembrolizumab inupadenant Dostarlimab SOC chemotherap...	18 Years -	iTeos Therapeutics

Spots Global Cancer Trial Database for gsk4428859a

Every month we try and update this database with for gsk4428859a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gsk4428859a

Every month we try and update this database with for gsk4428859a cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gsk4428859a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.