TIG-006: Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Detailed 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
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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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Part 1A - EOS-448 + anti-PD1 Participants will receive EOS-448 and anti-PD1 at every cycle |
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: pembrolizumab
Anti-PD-1 monoclonal antibody
|
Experimental: Part 1B - EOS-448 + inupadenant Participants will receive EOS-448 at every cycle and inupadenant on a ongoing basis |
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: inupadenant
A2A receptor antagonist
Other Names:
|
Experimental: Part 1C - EOS-448 + inupadenant Participants will receive EOS-448 at every cycle and inupadenant on a ongoing basis |
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: inupadenant
A2A receptor antagonist
Other Names:
|
Experimental: Part 1D - EOS-448 + dostarlimab Participants will receive EOS-448 and dostarlimab at every cycle |
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
|
Experimental: Part 1E - inupadenant HCl + dostarlimab Participants will receive dostarlimab at every cycle and inupadenant on a ongoing basis |
Drug: inupadenant
A2A receptor antagonist
Other Names:
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
|
Experimental: Part 1F - EOS-448 + dostarlimab + inupadenant HC Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on a ongoing basis |
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: inupadenant
A2A receptor antagonist
Other Names:
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
|
Experimental: Part 1G - EOS-448 + dostarlimab + chemotherapies Participants will receive EOS-448 and dostarlimab and chemotherapies at every cycle |
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
Drug: SOC chemotherapies
SOC chemotherapies in 1L NSCLC
|
Experimental: Part 2C - EOS-448 + dostarlimab Participants with HNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle |
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
|
Experimental: Part 2D - EOS-448 + dostarlimab Participants with HNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle |
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: Dostarlimab
Anti-PD-1 monoclonal antibody
|
Experimental: Part 2E - EOS-448 + inupadenant Participants with Melanoma 2L+ after anti-PD1 will receive EOS-448 at every cycle and inupadenant on a ongoing basis |
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: inupadenant
A2A receptor antagonist
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with DLT and Adverse Events [From first study treatment administration through Day 21-28 for DLT / Up to 120 days after the last dose]
- Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors [Up to 48 weeks]
- Percentage of participants with Objective Response as determined by Investigator [Until disease progression - Approximately 48 months]
Secondary Outcome Measures
- Duration of Response (DOR) [Until disease progression or death - Approximately 48 months]
- Disease Control Rate (DCR) [Until disease progression or death - Approximately 48 months]
- Progression-free-survival (PFS) [Until disease progression or death - Approximately 48 months]
- Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level [Up to 48 weeks]
- Percentage of participants with anti-drug antibodies to EOS884448 [Up to 48 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provide a signed written informed consent for the trial
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Have measurable disease, per RECIST v1.1
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Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1.
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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 :
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Have a histologically confirmed or cytologically confirmed newly diagnosed stage IV (M1a or M1b- AJCC 8th edition) non-squamous NSCLC OR squamous NSCLC.
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Are eligible to receive anti-PD(L)1 therapy combined with chemotherapy in first line metastatic setting
-
Part 2 (lung cancer, H&N)
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Have histologically or cytologically confirmed recurrent advanced or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
-
PD-L1 status positive
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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
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Part 1 : major surgery within 5 weeks before initiating treatment
-
Part 1 : Have received prior radiotherapy within 2 weeks of start of study treatment
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hackensack University Medical Center | Bergen | New Jersey | United States | 07601 |
2 | GZA Ziekenhuizen campus Sint-Augustinus | Antwerpen | Belgium | ||
3 | Cliniques universitaires St Luc-UCL | Brussels | Belgium | ||
4 | Institut de Cancérologie de l'Ouest | Nantes | France |
Sponsors and Collaborators
- iTeos Belgium SA
- GlaxoSmithKline
- iTeos Therapeutics
Investigators
- Study Director: Iteos Clinical Trials, iTeos Belgium SA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TIG-006