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Trial record 1 of 6 for:    EOs-448
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Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors (TIG-006)

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ClinicalTrials.gov Identifier: NCT05060432
Recruitment Status : Recruiting
First Posted : September 29, 2021
Last Update Posted : June 16, 2022
Sponsor:
Collaborators:
GlaxoSmithKline
iTeos Therapeutics
Information provided by (Responsible Party):
iTeos Therapeutics ( iTeos Belgium SA )

Study Description
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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
Advanced Cancer Lung Cancer Head and Neck Cancer Melanoma Drug: EOS-448 Drug: pembrolizumab Drug: inupadenant Drug: Dostarlimab Drug: SOC chemotherapies 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
  • 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
Actual Study Start Date : September 6, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • EOS884448
  • GSK4428859

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:
  • EOS884448
  • GSK4428859

Drug: inupadenant
A2A receptor antagonist
Other Name: EOS100850
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:
  • EOS884448
  • GSK4428859

Drug: inupadenant
A2A receptor antagonist
Other Name: EOS100850
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:
  • EOS884448
  • GSK4428859

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 Name: EOS100850

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:
  • EOS884448
  • GSK4428859

Drug: inupadenant
A2A receptor antagonist
Other Name: EOS100850

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:
  • EOS884448
  • GSK4428859

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:
  • EOS884448
  • GSK4428859

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:
  • EOS884448
  • GSK4428859

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:
  • EOS884448
  • GSK4428859

Drug: inupadenant
A2A receptor antagonist
Other Name: EOS100850


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with DLT and Adverse Events [ Time Frame: From first study treatment administration through Day 21-28 for DLT / Up to 120 days after the last dose ]
  2. Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors [ Time Frame: Up to 48 weeks ]
  3. Percentage of participants with Objective Response as determined by Investigator [ Time Frame: Until disease progression - Approximately 48 months ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Until disease progression or death - Approximately 48 months ]
  2. Disease Control Rate (DCR) [ Time Frame: Until disease progression or death - Approximately 48 months ]
  3. Progression-free-survival (PFS) [ Time Frame: Until disease progression or death - Approximately 48 months ]
  4. Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level [ Time Frame: Up to 48 weeks ]
  5. Percentage of participants with anti-drug antibodies to EOS884448 [ Time Frame: Up to 48 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05060432


Contacts
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Contact: iTeos Belgium SA +32 71 91 99 33 clinical_info@iteostherapeutics.com

Locations
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United States, New Jersey
Hackensack University Medical Center Recruiting
Bergen, New Jersey, United States, 07601
Contact: Clinical trials Unit         
Belgium
GZA Ziekenhuizen campus Sint-Augustinus Recruiting
Antwerpen, Belgium
Contact: Clinical Trials Unit         
Cliniques universitaires St Luc-UCL Recruiting
Brussels, Belgium
Contact: Clinical Trials Unit         
France
Institut de Cancérologie de l'Ouest Recruiting
Nantes, France
Contact: Clinical Trials Unit         
Sponsors and Collaborators
iTeos Belgium SA
GlaxoSmithKline
iTeos Therapeutics
Investigators
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Study Director: Iteos Clinical Trials iTeos Belgium SA
More Information
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Responsible Party: iTeos Belgium SA
ClinicalTrials.gov Identifier: NCT05060432    
Other Study ID Numbers: TIG-006
First Posted: September 29, 2021    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by iTeos Therapeutics ( iTeos Belgium SA ):
EOS884448
EOS-448
GSK4428859A
TIGIT
Anti-TIGIT
pembrolizumab
 dostarlimab
inupadenant
A2A Receptor antagonist
EOS-850
EOS100850
Anti-PD-1 monoclonal antibody
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Pembrolizumab
Dostarlimab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action