Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
a study on Cancer, General Lung Cancer Head and Neck Cancer Skin Cancer/Melanoma Solid Tumor Lung Tumor Head and Neck Tumor
Summary
- Eligibility
 - for people ages 18 years and up (full criteria)
 - Location
 - at UCSD
 - Dates
 - study startedstudy ends around
 
Description
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 tumors.
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
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
 
Keywords
Advanced Cancer, Lung Cancer, Head and Neck Cancer, Melanoma, EOS884448, GSK4428859A, TIGIT, Anti-TIGIT, EOS-448, pembrolizumab, dostarlimab, inupadenant, A2A Receptor antagonist, EOS-850, EOS100850, Anti-PD-1 monoclonal antibody, belrestotug, Lung Neoplasms, Head and Neck Neoplasms, SOC chemotherapies, EOS-448 + pembrolizumab, EOS-448 + inupadenant, EOS-448 + dostarlimab, inupadenant HCl + dostarlimab
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 
 - 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 CAN'T join 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)
 
Locations
- University of California San Diego
San Diego 5391811 California 5332921 92037 United States - Hackensack University Medical Center
Bergen 5095594 New Jersey 5101760 07601 United States 
Details
- Status
 - in progress, not accepting new patients
 - Start Date
 - Completion Date
 - (estimated)
 - Sponsor
 - iTeos Belgium SA
 - ID
 - NCT05060432
 - Phase
 - Phase 1/2 research study
 - Study Type
 - Interventional
 - Participants
 - About 153 people participating
 - Last Updated