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

Sponsor
iTeos Belgium SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05060432
Collaborator
GlaxoSmithKline (Industry), iTeos Therapeutics (Industry)
376
4
10
35.8
94
2.6

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

  • 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

Study Type:
Interventional
Anticipated 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 :
Sep 6, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

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:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • EOS100850
  • Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors [Up to 48 weeks]

    3. Percentage of participants with Objective Response as determined by Investigator [Until disease progression - Approximately 48 months]

    Secondary Outcome Measures

    1. Duration of Response (DOR) [Until disease progression or death - Approximately 48 months]

    2. Disease Control Rate (DCR) [Until disease progression or death - Approximately 48 months]

    3. Progression-free-survival (PFS) [Until disease progression or death - Approximately 48 months]

    4. Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level [Up to 48 weeks]

    5. Percentage of participants with anti-drug antibodies to EOS884448 [Up to 48 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.
    Responsible Party:
    iTeos Belgium SA
    ClinicalTrials.gov Identifier:
    NCT05060432
    Other Study ID Numbers:
    • TIG-006
    First Posted:
    Sep 29, 2021
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by iTeos Belgium SA
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 16, 2022