Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Advanced Cancer,Lung Cancer,Head and Neck Cancer,Melanoma
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
376
Est. Completion Date
Sep 30, 2024
Treatment type
Interventional
Sponsor
iTeos Therapeutics
ClinicalTrials.gov identifier
NCT05060432
Study number
TIG-006
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