Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors (TIG-006)

June 19, 2024 updated by: iTeos Belgium SA

A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A or belrestotug) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The combinations evaluated will be:

  • EOS-448 combined with pembrolizumab, an anti-PD-1 antibody
  • EOS-448 combined with inupadenant an investigational adenosine A2A receptor antagonist
  • EOS-448 combined with dostarlimab an anti-PD-1 antibody
  • inupadenant combined with dostarlimab
  • EOS-448 combined with inupadenant and dostarlimab
  • EOS-448 combined with dostarlimab and standard of care chemotherapies in participants with NSCLC

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires St Luc-UCL
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Mons, Belgium, 7000
        • CHU Helora
    • Antwerp
      • Antwerpen, Antwerp, Belgium, 2610
        • GZA Ziekenhuizen campus Sint-Augustinus
  • France
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Caen, France, 14033
        • CHU caen
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Nancy, France, 54519
        • Institut de Cancerologie Lorraine (ICL)
      • Nantes, France, 44805
        • Institut de cancerologie de l'ouest
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75013
        • Pitié Salpêtrière
      • Poitiers, France, 86000
        • CHU De Poitiers
      • Strasbourg, France, 67033
        • ICANS
  • Italy
      • Pavia, Italy, 27100
        • Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo
      • Ravenna, Italy, 48121
        • AUSL Della Romagna - Ospedale S. Maria delle Croci
    • Milan
      • Rozzano, Milan, Italy, 20089
        • IDB Center-Istituto Clinico Humanitas (IRCCS)
    • Turin
      • Candiolo, Turin, Italy, 10060
        • FPO-IRCCS Candiolo Cancer Insitute
  • Spain
      • Badajoz, Spain, 06006
        • Hospital Universitario de Badajoz
      • Barcelona, Spain, 08035
        • Vall d'Hebron
      • Jaén, Spain, 23007
        • Hospital Universitario de Jaén
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz - START MADRID
      • Málaga, Spain, 29004
        • Hospital Quirón Málaga
      • Pamplona, Spain, 31008
        • Hospital Universitario de Navarra
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46009
        • Fundacion Instituto Valenciano de Oncologia (IVO)
      • Valencia, Spain, 46014
        • Consorci Hospital Gral Univ Valencia
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Cataluña
      • Manresa, Cataluña, Spain, 08243
        • Hospital Althaia Xarxa Assitencial de Manresa
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital (London location)
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital (Sutton location)
  • United States
    • California
      • San Diego, California, United States, 92037
        • University Of California San Diego
    • New Jersey
      • Bergen, New Jersey, United States, 07601
        • Hackensack University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Provide a signed written informed consent for the trial
  • Have measurable disease, per RECIST v1.1
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1.
  • Have adequate organ functions
  • Part 1A/1B/1C/1D/1E/1F: Have histologically or cytologically confirmed advanced or metastatic solid tumor for whom no standard treatment with survival benefit is available

Part 1G (NSCLC):

  • Have a histologically confirmed or cytologically confirmed previously untreated stage IV OR stage III not amenable to curative chemoradiotherapy or surgery (AJCC 8th edition) nonsquamous NSCLC OR squamous NSCLC.
  • Are eligible to receive anti-PD(L)1 therapy combined with chemotherapy in first line metastatic setting

Part 2 (H&N cancer)

  • Have histologically or cytologically confirmed recurrent advanced or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
  • PD-L1 status positive

Exclusion Criteria:

  • Have received any anti-cancer therapy within 4 weeks prior to the first dose
  • Have received a live vaccine within 30 days prior to the first dose
  • Have known primary CNS cancer.
  • Have known CNS metastases unless previously treated and well controlled for at least 1 month
  • Have concomitant second malignancies unless a complete remission was achieved at least 2 years before study entry
  • Have a history of Grade ≥ 2 pneumonitis, active autoimmune disease, or persistent immune-mediated toxicity caused by immune checkpoint inhibitor therapy of Grade ≥ 2
  • Have toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.
  • Have uncontrolled or significant cardiovascular disease
  • Part 1: major surgery within 3 weeks before initiating treatment
  • Part 1: Have received prior radiotherapy within 2 weeks of start of study treatment
  • Part 2 (H&N cancer):
  • Have received prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Have received prior chemotherapy administered in the recurrent advanced or metastatic setting (except for systemic therapy completed > 6 months prior to screening if given as part of multimodal treatment for locally advanced disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1D - EOS-448 + dostarlimab
Participants will receive EOS-448 and dostarlimab at every cycle
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
Experimental: Part 1A - EOS-448 + pembrolizumab
Participants will receive EOS-448 and pembrolizumab at every cycle
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug
Drug: pembrolizumab
Anti-PD-1 monoclonal antibody
Experimental: Part 1B - EOS-448 + inupadenant
Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug
Drug: inupadenant
A2A receptor antagonist
Other Names:
  • EOS100850
Experimental: Part 1C - EOS-448 + inupadenant
Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug
Drug: inupadenant
A2A receptor antagonist
Other Names:
  • EOS100850
Experimental: Part 1E - inupadenant HCl + dostarlimab
Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis
Drug: inupadenant
A2A receptor antagonist
Other Names:
  • EOS100850
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
Experimental: Part 1F - EOS-448 + dostarlimab + inupadenant HC
Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug
Drug: inupadenant
A2A receptor antagonist
Other Names:
  • EOS100850
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
Experimental: Part 1G - EOS-448 + dostarlimab + chemotherapies
Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
Drug: SOC chemotherapies
SOC chemotherapies in 1L mNSCLC
Experimental: Part 2C - EOS-448 + dostarlimab
Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
Experimental: Part 2D - EOS-448 + dostarlimab
Participants with 1L mHNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of participants with DLT and Adverse Events
Time Frame: From first study treatment administration through Day 21-28 for DLT / Up to 120 days after the last dose
From first study treatment administration through Day 21-28 for DLT / Up to 120 days after the last dose
Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors
Time Frame: Up to 48 weeks
Up to 48 weeks
Percentage of participants with Objective Response as determined by Investigator
Time Frame: Until disease progression - Approximately 48 months
Until disease progression - Approximately 48 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Duration of Response (DOR)
Time Frame: Until disease progression or death - Approximately 48 months
Until disease progression or death - Approximately 48 months
Disease Control Rate (DCR)
Time Frame: Until disease progression or death - Approximately 48 months
Until disease progression or death - Approximately 48 months
Progression-free-survival (PFS)
Time Frame: Until disease progression or death - Approximately 48 months
Until disease progression or death - Approximately 48 months
Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level
Time Frame: Up to 48 weeks
Up to 48 weeks
Percentage of participants with anti-drug antibodies to EOS884448
Time Frame: Up to 48 weeks
Up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
iTeos Belgium SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline
iTeos Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Iteos Clinical Trials, iTeos Belgium SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TIG-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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