Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors (TIG-006)
Advanced Cancer, Lung Cancer, Head and Neck Cancer
About this trial
This is an interventional treatment trial for Advanced Cancer focused on measuring EOS884448, GSK4428859A, TIGIT, Anti-TIGIT, EOS-448, pembrolizumab, dostarlimab, inupadenant, A2A Receptor antagonist, EOS-850, EOS100850, Anti-PD-1 monoclonal antibody
Eligibility Criteria
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 :
- 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)
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 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.
Sites / Locations
- Hackensack University Medical CenterRecruiting
- GZA Ziekenhuizen campus Sint-AugustinusRecruiting
- Cliniques universitaires St Luc-UCLRecruiting
- Institut de Cancérologie de l'OuestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Part 1A - EOS-448 + anti-PD1
Part 1B - EOS-448 + inupadenant
Part 1C - EOS-448 + inupadenant
Part 1D - EOS-448 + dostarlimab
Part 1E - inupadenant HCl + dostarlimab
Part 1F - EOS-448 + dostarlimab + inupadenant HC
Part 1G - EOS-448 + dostarlimab + chemotherapies
Part 2C - EOS-448 + dostarlimab
Part 2D - EOS-448 + dostarlimab
Part 2E - EOS-448 + inupadenant
Participants will receive EOS-448 and anti-PD1 at every cycle
Participants will receive EOS-448 at every cycle and inupadenant on a ongoing basis
Participants will receive EOS-448 at every cycle and inupadenant on a ongoing basis
Participants will receive EOS-448 and dostarlimab at every cycle
Participants will receive dostarlimab at every cycle and inupadenant on a ongoing basis
Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on a ongoing basis
Participants will receive EOS-448 and dostarlimab and chemotherapies at every cycle
Participants with HNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
Participants with HNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle
Participants with Melanoma 2L+ after anti-PD1 will receive EOS-448 at every cycle and inupadenant on a ongoing basis