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Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors (TIG-006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05060432
Recruitment Status : Recruiting
First Posted : September 29, 2021
Last Update Posted : December 27, 2023
Sponsor:
Collaborators:
GlaxoSmithKline
iTeos Therapeutics
Information provided by (Responsible Party):
iTeos Therapeutics ( iTeos Belgium SA )

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 or belrestotug) 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
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 : September 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1A - EOS-448 + pembrolizumab
Participants will receive EOS-448 and pembrolizumab at every cycle
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug

Drug: pembrolizumab
Anti-PD-1 monoclonal antibody

Experimental: Part 1B - EOS-448 + inupadenant
Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug

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 an ongoing basis
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug

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
  • belrestotug

Drug: Dostarlimab
Anti-PD-1 monoclonal antibody

Experimental: Part 1E - inupadenant HCl + dostarlimab
Participants will receive dostarlimab at every cycle and inupadenant on an 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 an ongoing basis
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug

Drug: inupadenant
A2A receptor antagonist
Other Name: EOS100850

Drug: Dostarlimab
Anti-PD-1 monoclonal antibody

Experimental: Part 1G - EOS-448 + dostarlimab + chemotherapies
Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug

Drug: Dostarlimab
Anti-PD-1 monoclonal antibody

Drug: SOC chemotherapies
SOC chemotherapies in 1L mNSCLC

Experimental: Part 2C - EOS-448 + dostarlimab
Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug

Drug: Dostarlimab
Anti-PD-1 monoclonal antibody

Experimental: Part 2D - EOS-448 + dostarlimab
Participants with 1L mHNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle
Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
  • EOS884448
  • GSK4428859
  • belrestotug

Drug: Dostarlimab
Anti-PD-1 monoclonal antibody




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 ]


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 (NSCLC):

  • Have a histologically confirmed or cytologically confirmed previously untreated stage IV OR stage III not amenable to curative chemoradiotherapy or surgery (AJCC 8th edition) nonsquamous NSCLC OR squamous NSCLC.
  • Are eligible to receive anti-PD(L)1 therapy combined with chemotherapy in first line metastatic setting

Part 2 (H&N cancer)

  • Have histologically or cytologically confirmed recurrent advanced or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
  • PD-L1 status positive

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 3 weeks before initiating treatment
  • Part 1: Have received prior radiotherapy within 2 weeks of start of study treatment
  • Part 2 (H&N cancer):
  • Have received prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Have received prior chemotherapy administered in the recurrent advanced or metastatic setting (except for systemic therapy completed > 6 months prior to screening if given as part of multimodal treatment for locally advanced disease)

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
Show Show 41 study locations
Sponsors and Collaborators
iTeos Belgium SA
GlaxoSmithKline
iTeos Therapeutics
Investigators
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Study Director: Iteos Clinical Trials iTeos Belgium SA
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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: December 27, 2023
Last Verified: December 2023
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
GSK4428859A
TIGIT
Anti-TIGIT
EOS-448
pembrolizumab
dostarlimab
inupadenant
A2A Receptor antagonist
EOS-850
EOS100850
Anti-PD-1 monoclonal antibody
belrestotug
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