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
- 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 California 92037 United States - Hackensack University Medical Center
Bergen New Jersey 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