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 Head and Neck Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Diego, California and other locations
- Dates
- study startedcompletion 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, 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 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 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
accepting new patients
San Diego California 92037 United States - Innovative Clinical Research Institute, LLC
accepting new patients
Whittier California 90603 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- iTeos Belgium SA
- ID
- NCT05060432
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 254 study participants
- Last Updated
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