Melanoma Clinical Trial
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) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.
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
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 :
Have a histologically confirmed or cytologically confirmed newly diagnosed stage IV (M1a or M1b- AJCC 8th edition) non-squamous NSCLC OR squamous NSCLC.
Are eligible to receive anti-PD(L)1 therapy combined with chemotherapy in first line metastatic setting
Part 2 (lung cancer, H&N)
Have histologically or cytologically confirmed recurrent advanced or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
PD-L1 status positive
Part 2 (melanoma) : progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb)
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 â‰¥ 2 pneumonitis, active autoimmune disease, or persistent immune-mediated toxicity caused by immune checkpoint inhibitor therapy of Grade â‰¥ 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 5 weeks before initiating treatment
Part 1 : Have received prior radiotherapy within 2 weeks of start of study treatment
Part 2 (lung cancer, H&N) :Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), reactive oxygen species (ROS1) or any other genomic aberration approved directed therapy is indicated as primary therapy.
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There is 1 Location for this study
Bergen New Jersey, 07601, United States More Info
Antwerpen , , Belgium More Info
Brussels , , Belgium More Info
Nantes , , France More Info
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