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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.