Melanoma Clinical Trial

Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

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) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.

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Full Description

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

View Eligibility Criteria

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.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

376

Study ID:

NCT05060432

Recruitment Status:

Recruiting

Sponsor:

iTeos Belgium SA

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There is 1 Location for this study

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Hackensack University Medical Center
Bergen New Jersey, 07601, United States More Info
Clinical trials Unit
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GZA Ziekenhuizen campus Sint-Augustinus
Antwerpen , , Belgium More Info
Clinical Trials Unit
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Cliniques universitaires St Luc-UCL
Brussels , , Belgium More Info
Clinical Trials Unit
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Institut de Cancérologie de l'Ouest
Nantes , , France More Info
Clinical Trials Unit
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How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

376

Study ID:

NCT05060432

Recruitment Status:

Recruiting

Sponsor:


iTeos Belgium SA

How clear is this clinincal trial information?

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