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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Advanced Cancer, Lung Cancer, Head and Neck Cancer, Melanoma

In brief

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.

Key facts

Study ID

NCT05060432

Run by

iTeos Belgium SA

People needed

153

Starts

2021-09-06

Expected to finish

2025-07-01

Last updated by the study team

2024-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of California San Diego — San Diego, California, United States
• Hackensack University Medical Center — Bergen, New Jersey, United States
• GZA Ziekenhuizen campus Sint-Augustinus — Antwerp, Antwerp, Belgium
• Cliniques universitaires St Luc-UCL — Brussels, Belgium
• Jessa Ziekenhuis — Hasselt, Belgium
• UZ Leuven — Leuven, Belgium
• CHU Helora — Mons, Belgium
• Hôpital Saint André — Bordeaux, France
• CHU Caen — Caen, France
• Centre Georges Francois Leclerc — Dijon, France
• Clinique Victor Hugo — Le Mans, France
• Centre Oscar Lambret — Lille, France
• Centre Léon Bérard — Lyon, France
• Institut de Cancerologie Lorraine (ICL) — Nancy, France
• Institut de Cancérologie de l'Ouest — Nantes, France
• Centre Antoine Lacassagne — Nice, France
• Pitié Salpêtrière — Paris, France
• CHU de POITIERS — Poitiers, France
• ICANS — Strasbourg, France
• IDB Center-Istituto Clinico Humanitas (IRCCS) — Rozzano, Milan, Italy
• FPO-IRCCS Candiolo Cancer Insitute — Candiolo, Turin, Italy
• Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
• AUSL Della Romagna - Ospedale S. Maria delle Croci — Ravenna, Italy
• Hospital Althaia Xarxa Assitencial de Manresa — Manresa, Catalonia, Spain
• Hospital Universitario de Badajoz — Badajoz, Spain

Full record on ClinicalTrials.gov

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