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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05060432
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

iTeos Belgium SA
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Iteos Clinical Trials
Principal Investigator Affiliation iTeos Belgium SA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Belgium, France, Italy, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Cancer, Lung Cancer, Head and Neck Cancer, Melanoma
Additional Details

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

Arms & Interventions

Arms

Experimental: Part 1A - EOS-448 + pembrolizumab

Participants will receive EOS-448 and pembrolizumab at every cycle

Experimental: Part 1B - EOS-448 + inupadenant

Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis

Experimental: Part 1C - EOS-448 + inupadenant

Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis

Experimental: Part 1D - EOS-448 + dostarlimab

Participants will receive EOS-448 and dostarlimab at every cycle

Experimental: Part 1E - inupadenant HCl + dostarlimab

Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis

Experimental: Part 1F - EOS-448 + dostarlimab + inupadenant HC

Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis

Experimental: Part 1G - EOS-448 + dostarlimab + chemotherapies

Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle

Experimental: Part 2C - EOS-448 + dostarlimab

Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle

Experimental: Part 2D - EOS-448 + dostarlimab

Participants with 1L mHNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle

Interventions

Drug: - EOS-448

Anti-TIGIT monoclonal antibody

Drug: - pembrolizumab

Anti-PD-1 monoclonal antibody

Drug: - inupadenant

A2A receptor antagonist

Drug: - Dostarlimab

Anti-PD-1 monoclonal antibody

Drug: - SOC chemotherapies

SOC chemotherapies in 1L mNSCLC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Diego, San Diego 5391811, California 5332921

Status

Address

University of California San Diego

San Diego 5391811, California 5332921, 92037

Hackensack University Medical Center, Bergen 5095594, New Jersey 5101760

Status

Address

Hackensack University Medical Center

Bergen 5095594, New Jersey 5101760, 07601

International Sites

GZA Ziekenhuizen campus Sint-Augustinus, Antwerp 2803138, Antwerp, Belgium

Status

Address

GZA Ziekenhuizen campus Sint-Augustinus

Antwerp 2803138, Antwerp, 2610

Cliniques universitaires St Luc-UCL, Brussels 2800866, Belgium

Status

Address

Cliniques universitaires St Luc-UCL

Brussels 2800866, , 1200

Jessa Ziekenhuis, Hasselt 2796491, Belgium

Status

Address

Jessa Ziekenhuis

Hasselt 2796491, , 3500

UZ Leuven, Leuven 2792482, Belgium

Status

Address

UZ Leuven

Leuven 2792482, , 3000

CHU Helora, Mons 2790869, Belgium

Status

Address

CHU Helora

Mons 2790869, , 7000

Hôpital Saint André, Bordeaux 3031582, France

Status

Address

Hôpital Saint André

Bordeaux 3031582, , 33075

CHU Caen, Caen 3029241, France

Status

Address

CHU Caen

Caen 3029241, , 14033

Centre Georges Francois Leclerc, Dijon 3021372, France

Status

Address

Centre Georges Francois Leclerc

Dijon 3021372, , 21079

Clinique Victor Hugo, Le Mans 3003603, France

Status

Address

Clinique Victor Hugo

Le Mans 3003603, , 72000

Centre Oscar Lambret, Lille 2998324, France

Status

Address

Centre Oscar Lambret

Lille 2998324, , 59000

Centre Léon Bérard, Lyon 2996944, France

Status

Address

Centre Léon Bérard

Lyon 2996944, , 69373

Institut de Cancerologie Lorraine (ICL), Nancy 2990999, France

Status

Address

Institut de Cancerologie Lorraine (ICL)

Nancy 2990999, , 54519

Institut de Cancérologie de l'Ouest, Nantes 2990969, France

Status

Address

Institut de Cancérologie de l'Ouest

Nantes 2990969, , 44805

Centre Antoine Lacassagne, Nice 2990440, France

Status

Address

Centre Antoine Lacassagne

Nice 2990440, , 06189

Pitié Salpêtrière, Paris 2988507, France

Status

Address

Pitié Salpêtrière

Paris 2988507, , 75013

CHU de POITIERS, Poitiers 2986495, France

Status

Address

CHU de POITIERS

Poitiers 2986495, , 86000

ICANS, Strasbourg 2973783, France

Status

Address

ICANS

Strasbourg 2973783, , 67033

Rozzano 3168837, Milan, Italy

Status

Address

IDB Center-Istituto Clinico Humanitas (IRCCS)

Rozzano 3168837, Milan, 20089

FPO-IRCCS Candiolo Cancer Insitute, Candiolo 3180861, Turin, Italy

Status

Address

FPO-IRCCS Candiolo Cancer Insitute

Candiolo 3180861, Turin, 10060

Pavia 3171366, Italy

Status

Address

Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo

Pavia 3171366, , 27100

Ravenna 3169561, Italy

Status

Address

AUSL Della Romagna - Ospedale S. Maria delle Croci

Ravenna 3169561, , 48121

Manresa 3117533, Catalonia 3336901, Spain

Status

Address

Hospital Althaia Xarxa Assitencial de Manresa

Manresa 3117533, Catalonia 3336901, 08243

Hospital Universitario de Badajoz, Badajoz 2521420, Spain

Status

Address

Hospital Universitario de Badajoz

Badajoz 2521420, , 06006

Vall d'Hebron, Barcelona 3128760, Spain

Status

Address

Vall d'Hebron

Barcelona 3128760, , 08035

Hospital Universitario de Jaen, Jaén 2516395, Spain

Status

Address

Hospital Universitario de Jaen

Jaén 2516395, , 23007

Hospital Clinico San Carlos, Madrid 3117735, Spain

Status

Address

Hospital Clinico San Carlos

Madrid 3117735, , 28040

Madrid 3117735, Spain

Status

Address

Hospital Universitario Fundación Jiménez Díaz - START Madrid

Madrid 3117735, , 28040

Hospital Universitario 12 de Octubre, Madrid 3117735, Spain

Status

Address

Hospital Universitario 12 de Octubre

Madrid 3117735, , 28041

Hospital Quirón Málaga, Málaga 2514256, Spain

Status

Address

Hospital Quirón Málaga

Málaga 2514256, , 29004

Hospital Universitario de Navarra, Pamplona 3114472, Spain

Status

Address

Hospital Universitario de Navarra

Pamplona 3114472, , 31008

Hospital Universitario Virgen Macarena, Seville 2510911, Spain

Status

Address

Hospital Universitario Virgen Macarena

Seville 2510911, , 41009

Valencia 2509954, Spain

Status

Address

Fundacion Instituto Valenciano de Oncologia (IVO)

Valencia 2509954, , 46009

Consorci Hospital Gral Univ Valencia, Valencia 2509954, Spain

Status

Address

Consorci Hospital Gral Univ Valencia

Valencia 2509954, , 46014

Valencia 2509954, Spain

Status

Address

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

Valencia 2509954, , 46026

Hospital Universitario Miguel Servet, Zaragoza 3104324, Spain

Status

Address

Hospital Universitario Miguel Servet

Zaragoza 3104324, , 50009

Royal Marsden Hospital (Sutton location), Sutton 2636503, Surrey, United Kingdom

Status

Address

Royal Marsden Hospital (Sutton location)

Sutton 2636503, Surrey, SM2 5PT

Addenbrooke's Hospital, Cambridge 2653941, United Kingdom

Status

Address

Addenbrooke's Hospital

Cambridge 2653941, , CB2 0QQ

Royal Marsden Hospital (London location), London 2643743, United Kingdom

Status

Address

Royal Marsden Hospital (London location)

London 2643743, , SW3 6JJ

Hammersmith Hospital, London 2643743, United Kingdom

Status

Address

Hammersmith Hospital

London 2643743, , W12 0HS

Nottingham City Hospital, Nottingham 2641170, United Kingdom

Status

Address

Nottingham City Hospital

Nottingham 2641170, , NG5 1PB

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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