AzTrials
AzTrials

Advanced CancerPhase 1/2TIG-006NCT05060432

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

A Phase 1/2 study testing EOS-448, pembrolizumab and inupadenant in people with Advanced Cancer and Lung Cancer, run by iTeos Belgium SA at 42 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Lung Cancer, Head and Neck Cancer
What is being tested?
EOS-448, pembrolizumab and inupadenant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
42 sitesin 6 countries
Study dates
6 Sep 2021to Jul 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

42 sites in 6 countries.

42 sites in 6 countries

Spain14 sites

  • Hospital Universitario de Badajoz

    Badajoz, 06006

  • Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario de Jaen

    Jaén, 23007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz - START Madrid

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Quirón Málaga

    Málaga, 29004

  • Hospital Althaia Xarxa Assitencial de Manresa

    Manresa, Catalonia, 08243

  • Hospital Universitario de Navarra

    Pamplona, 31008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Fundacion Instituto Valenciano de Oncologia (IVO)

    Valencia, 46009

  • Consorci Hospital Gral Univ Valencia

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

France12 sites

  • Hôpital Saint André

    Bordeaux, 33075

  • CHU Caen

    Caen, 14033

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • Clinique Victor Hugo

    Le Mans, 72000

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Léon Bérard

    Lyon, 69373

  • Institut de Cancerologie Lorraine (ICL)

    Nancy, 54519

  • Institut de Cancérologie de l'Ouest

    Nantes, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Pitié Salpêtrière

    Paris, 75013

  • CHU de POITIERS

    Poitiers, 86000

  • ICANS

    Strasbourg, 67033

Other trials in France

Belgium5 sites

  • GZA Ziekenhuizen campus Sint-Augustinus

    Antwerp, Antwerp, 2610

  • Cliniques universitaires St Luc-UCL

    Brussels, 1200

  • Jessa Ziekenhuis

    Hasselt, 3500

  • UZ Leuven

    Leuven, 3000

  • CHU Helora

    Mons, 7000

Other trials in Belgium

United Kingdom5 sites

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Royal Marsden Hospital (London location)

    London, SW3 6JJ

  • Hammersmith Hospital

    London, W12 0HS

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Royal Marsden Hospital (Sutton location)

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Italy4 sites

  • FPO-IRCCS Candiolo Cancer Insitute

    Candiolo, Turin, 10060

  • Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • AUSL Della Romagna - Ospedale S. Maria delle Croci

    Ravenna, 48121

  • IDB Center-Istituto Clinico Humanitas (IRCCS)

    Rozzano, Milan, 20089

Other trials in Italy

United States2 sites

  • Hackensack University Medical Center

    Bergen, New Jersey, 07601

  • University of California San Diego

    San Diego, California, 92037

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
EOS-448, pembrolizumab, inupadenant, Dostarlimab, SOC chemotherapies
Keywords
EOS884448, GSK4428859A, TIGIT, Anti-TIGIT, EOS-448, pembrolizumab, dostarlimab, inupadenant, A2A Receptor antagonist, EOS-850, EOS100850, Anti-PD-1 monoclonal antibody, belrestotug
Medical subject headings
Lung Neoplasms, Head and Neck Neoplasms, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EOS-448Drug

    Also called EOS884448, GSK4428859, belrestotug

    Anti-TIGIT monoclonal antibody

  • pembrolizumabDrug

    Anti-PD-1 monoclonal antibody

  • inupadenantDrug

    Also called EOS100850

    A2A receptor antagonist

  • DostarlimabDrug

    Anti-PD-1 monoclonal antibody

  • SOC chemotherapiesDrug

    SOC chemotherapies in 1L mNSCLC

Study groups in NCT05060432
Study groupRoleWhat they receive
Part 1A - EOS-448 + pembrolizumabExperimentalParticipants will receive EOS-448 and pembrolizumab at every cycle
Receives: Drug: EOS-448; Drug: pembrolizumab
Part 1B - EOS-448 + inupadenantExperimentalParticipants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Receives: Drug: EOS-448; Drug: inupadenant
Part 1C - EOS-448 + inupadenantExperimentalParticipants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Receives: Drug: EOS-448; Drug: inupadenant
Part 1D - EOS-448 + dostarlimabExperimentalParticipants will receive EOS-448 and dostarlimab at every cycle
Receives: Drug: EOS-448; Drug: Dostarlimab
Part 1E - inupadenant HCl + dostarlimabExperimentalParticipants will receive dostarlimab at every cycle and inupadenant on an ongoing basis
Receives: Drug: inupadenant; Drug: Dostarlimab
Part 1F - EOS-448 + dostarlimab + inupadenant HCExperimentalParticipants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis
Receives: Drug: EOS-448; Drug: inupadenant; Drug: Dostarlimab
Part 1G - EOS-448 + dostarlimab + chemotherapiesExperimentalParticipants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle
Receives: Drug: EOS-448; Drug: Dostarlimab; Drug: SOC chemotherapies
Part 2C - EOS-448 + dostarlimabExperimentalParticipants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
Receives: Drug: EOS-448; Drug: Dostarlimab
Part 2D - EOS-448 + dostarlimabExperimentalParticipants with 1L mHNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle
Receives: Drug: EOS-448; Drug: Dostarlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with DLT and Adverse Events

    Measured: From first study treatment administration through Day 21-28 for DLT / Up to 120 days after the last dose

  2. Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors

    Measured: Up to 48 weeks

  3. Percentage of participants with Objective Response as determined by Investigator

    Measured: Until disease progression - Approximately 48 months

Secondary outcomes (5)

  1. Duration of Response (DOR)

    Measured: Until disease progression or death - Approximately 48 months

  2. Disease Control Rate (DCR)

    Measured: Until disease progression or death - Approximately 48 months

  3. Progression-free-survival (PFS)

    Measured: Until disease progression or death - Approximately 48 months

  4. Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level

    Measured: Up to 48 weeks

  5. Percentage of participants with anti-drug antibodies to EOS884448

    Measured: Up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2021
  2. Study start6 Sep 2021
  3. Primary completionJul 2024 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05060432
Sponsor's protocol ID
TIG-006
Acronym
TIG-006
Status last verified
Jun 2024
First submitted
6 Sep 2021
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EOS-448, pembrolizumab and inupadenant in people with Advanced Cancer and Lung Cancer, run by iTeos Belgium SA at 42 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Spain, France, Belgium, United Kingdom, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05060432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in