UnknownPhase 1 / Phase 2NCT05060432

Study of EOS-448 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.

Checked against the public recordLast updated Jun 21, 2024 · Source: ClinicalTrials.gov

StatusUnknown
PhasePhase 1 / Phase 2
U.S. locations42
SponsoriTeos Belgium SA
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
iTeos Belgium SA
Interventions being studied
Drug: EOS-448; Drug: pembrolizumab; Drug: inupadenant; Drug: Dostarlimab; Drug: SOC chemotherapies
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California San DiegoSan Diego, California
  • Hackensack University Medical CenterBergen, New Jersey
  • GZA Ziekenhuizen campus Sint-AugustinusAntwerp, Antwerp
  • Cliniques universitaires St Luc-UCLBrussels
  • Jessa ZiekenhuisHasselt
  • UZ LeuvenLeuven
  • CHU HeloraMons
  • Hôpital Saint AndréBordeaux
  • CHU CaenCaen
  • Centre Georges Francois LeclercDijon
  • Clinique Victor HugoLe Mans
  • Centre Oscar LambretLille

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 21, 2024. Always confirm current availability with the study team.

View original record ↗