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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 : December 27, 2023
Sponsor:
Collaborators:
GlaxoSmithKline
iTeos Therapeutics
Information provided by (Responsible Party):
iTeos Therapeutics ( iTeos Belgium SA )

Tracking Information
First Submitted Date  ICMJE September 6, 2021
First Posted Date  ICMJE September 29, 2021
Last Update Posted Date December 27, 2023
Actual Study Start Date  ICMJE September 6, 2021
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2021)
  • 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 ]
  • Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors [ Time Frame: Up to 48 weeks ]
  • Percentage of participants with Objective Response as determined by Investigator [ Time Frame: Until disease progression - Approximately 48 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2021)
  • Duration of Response (DOR) [ Time Frame: Until disease progression or death - Approximately 48 months ]
  • Disease Control Rate (DCR) [ Time Frame: Until disease progression or death - Approximately 48 months ]
  • Progression-free-survival (PFS) [ Time Frame: Until disease progression or death - Approximately 48 months ]
  • Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level [ Time Frame: Up to 48 weeks ]
  • Percentage of participants with anti-drug antibodies to EOS884448 [ Time Frame: Up to 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: September 27, 2021)
  • Change from baseline in absolute cell count in the tumor and in peripheral blood [ Time Frame: Up to 48 weeks ]
  • Frequency of activation/exhaustion markers in the tumor and in peripheral blood [ Time Frame: Up to 48 weeks ]
 
Descriptive Information
Brief Title  ICMJE Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Lung Cancer
  • Head and Neck Cancer
  • Melanoma
Intervention  ICMJE
  • Drug: EOS-448
    Anti-TIGIT monoclonal antibody
    Other Names:
    • EOS884448
    • GSK4428859
    • belrestotug
  • Drug: pembrolizumab
    Anti-PD-1 monoclonal antibody
  • Drug: inupadenant
    A2A receptor antagonist
    Other Name: EOS100850
  • Drug: Dostarlimab
    Anti-PD-1 monoclonal antibody
  • Drug: SOC chemotherapies
    SOC chemotherapies in 1L mNSCLC
Study Arms  ICMJE
  • Experimental: Part 1A - EOS-448 + pembrolizumab
    Participants will receive EOS-448 and pembrolizumab at every cycle
    Interventions:
    • Drug: EOS-448
    • Drug: pembrolizumab
  • Experimental: Part 1B - EOS-448 + inupadenant
    Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
    Interventions:
    • Drug: EOS-448
    • Drug: inupadenant
  • Experimental: Part 1C - EOS-448 + inupadenant
    Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
    Interventions:
    • Drug: EOS-448
    • Drug: inupadenant
  • Experimental: Part 1D - EOS-448 + dostarlimab
    Participants will receive EOS-448 and dostarlimab at every cycle
    Interventions:
    • Drug: EOS-448
    • Drug: Dostarlimab
  • Experimental: Part 1E - inupadenant HCl + dostarlimab
    Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis
    Interventions:
    • Drug: inupadenant
    • Drug: Dostarlimab
  • Experimental: Part 1F - EOS-448 + dostarlimab + inupadenant HC
    Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis
    Interventions:
    • Drug: EOS-448
    • Drug: inupadenant
    • Drug: Dostarlimab
  • Experimental: Part 1G - EOS-448 + dostarlimab + chemotherapies
    Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle
    Interventions:
    • Drug: EOS-448
    • Drug: Dostarlimab
    • Drug: SOC chemotherapies
  • Experimental: Part 2C - EOS-448 + dostarlimab
    Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
    Interventions:
    • Drug: EOS-448
    • Drug: Dostarlimab
  • Experimental: Part 2D - EOS-448 + dostarlimab
    Participants with 1L mHNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle
    Interventions:
    • Drug: EOS-448
    • Drug: Dostarlimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2023)
254
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2021)
276
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: iTeos Belgium SA +32 71 91 99 33 clinical_info@iteostherapeutics.com
Listed Location Countries  ICMJE Belgium,   France,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05060432
Other Study ID Numbers  ICMJE TIG-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party iTeos Therapeutics ( iTeos Belgium SA )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE iTeos Belgium SA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • GlaxoSmithKline
  • iTeos Therapeutics
Investigators  ICMJE
Study Director: Iteos Clinical Trials iTeos Belgium SA
PRS Account iTeos Therapeutics
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP