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

Primary Purpose

Advanced Cancer, Lung Cancer, Head and Neck Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
EOS-448
pembrolizumab
inupadenant
Dostarlimab
SOC chemotherapies
Sponsored by
iTeos Belgium SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring EOS884448, GSK4428859A, TIGIT, Anti-TIGIT, EOS-448, pembrolizumab, dostarlimab, inupadenant, A2A Receptor antagonist, EOS-850, EOS100850, Anti-PD-1 monoclonal antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hackensack University Medical CenterRecruiting
  • GZA Ziekenhuizen campus Sint-AugustinusRecruiting
  • Cliniques universitaires St Luc-UCLRecruiting
  • Institut de Cancérologie de l'OuestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1A - EOS-448 + anti-PD1

Part 1B - EOS-448 + inupadenant

Part 1C - EOS-448 + inupadenant

Part 1D - EOS-448 + dostarlimab

Part 1E - inupadenant HCl + dostarlimab

Part 1F - EOS-448 + dostarlimab + inupadenant HC

Part 1G - EOS-448 + dostarlimab + chemotherapies

Part 2C - EOS-448 + dostarlimab

Part 2D - EOS-448 + dostarlimab

Part 2E - EOS-448 + inupadenant

Arm Description

Participants will receive EOS-448 and anti-PD1 at every cycle

Participants will receive EOS-448 at every cycle and inupadenant on a ongoing basis

Participants will receive EOS-448 at every cycle and inupadenant on a ongoing basis

Participants will receive EOS-448 and dostarlimab at every cycle

Participants will receive dostarlimab at every cycle and inupadenant on a ongoing basis

Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on a ongoing basis

Participants will receive EOS-448 and dostarlimab and chemotherapies at every cycle

Participants with HNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle

Participants with HNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle

Participants with Melanoma 2L+ after anti-PD1 will receive EOS-448 at every cycle and inupadenant on a ongoing basis

Outcomes

Primary Outcome Measures

Percentage of participants with DLT and Adverse Events
Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors
Percentage of participants with Objective Response as determined by Investigator

Secondary Outcome Measures

Duration of Response (DOR)
Disease Control Rate (DCR)
Progression-free-survival (PFS)
Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level
Percentage of participants with anti-drug antibodies to EOS884448

Full Information

First Posted
September 6, 2021
Last Updated
July 10, 2023
Sponsor
iTeos Belgium SA
Collaborators
GlaxoSmithKline, iTeos Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05060432
Brief Title
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
Acronym
TIG-006
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iTeos Belgium SA
Collaborators
GlaxoSmithKline, iTeos Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Lung Cancer, Head and Neck Cancer, Melanoma
Keywords
EOS884448, GSK4428859A, TIGIT, Anti-TIGIT, EOS-448, pembrolizumab, dostarlimab, inupadenant, A2A Receptor antagonist, EOS-850, EOS100850, Anti-PD-1 monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
376 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1A - EOS-448 + anti-PD1
Arm Type
Experimental
Arm Description
Participants will receive EOS-448 and anti-PD1 at every cycle
Arm Title
Part 1B - EOS-448 + inupadenant
Arm Type
Experimental
Arm Description
Participants will receive EOS-448 at every cycle and inupadenant on a ongoing basis
Arm Title
Part 1C - EOS-448 + inupadenant
Arm Type
Experimental
Arm Description
Participants will receive EOS-448 at every cycle and inupadenant on a ongoing basis
Arm Title
Part 1D - EOS-448 + dostarlimab
Arm Type
Experimental
Arm Description
Participants will receive EOS-448 and dostarlimab at every cycle
Arm Title
Part 1E - inupadenant HCl + dostarlimab
Arm Type
Experimental
Arm Description
Participants will receive dostarlimab at every cycle and inupadenant on a ongoing basis
Arm Title
Part 1F - EOS-448 + dostarlimab + inupadenant HC
Arm Type
Experimental
Arm Description
Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on a ongoing basis
Arm Title
Part 1G - EOS-448 + dostarlimab + chemotherapies
Arm Type
Experimental
Arm Description
Participants will receive EOS-448 and dostarlimab and chemotherapies at every cycle
Arm Title
Part 2C - EOS-448 + dostarlimab
Arm Type
Experimental
Arm Description
Participants with HNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
Arm Title
Part 2D - EOS-448 + dostarlimab
Arm Type
Experimental
Arm Description
Participants with HNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle
Arm Title
Part 2E - EOS-448 + inupadenant
Arm Type
Experimental
Arm Description
Participants with Melanoma 2L+ after anti-PD1 will receive EOS-448 at every cycle and inupadenant on a ongoing basis
Intervention Type
Drug
Intervention Name(s)
EOS-448
Other Intervention Name(s)
EOS884448, GSK4428859
Intervention Description
Anti-TIGIT monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
pembrolizumab
Intervention Description
Anti-PD-1 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
inupadenant
Other Intervention Name(s)
EOS100850
Intervention Description
A2A receptor antagonist
Intervention Type
Drug
Intervention Name(s)
Dostarlimab
Intervention Description
Anti-PD-1 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
SOC chemotherapies
Intervention Description
SOC chemotherapies in 1L NSCLC
Primary Outcome Measure Information:
Title
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
Title
Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors
Time Frame
Up to 48 weeks
Title
Percentage of participants with Objective Response as determined by Investigator
Time Frame
Until disease progression - Approximately 48 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Time Frame
Until disease progression or death - Approximately 48 months
Title
Disease Control Rate (DCR)
Time Frame
Until disease progression or death - Approximately 48 months
Title
Progression-free-survival (PFS)
Time Frame
Until disease progression or death - Approximately 48 months
Title
Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level
Time Frame
Up to 48 weeks
Title
Percentage of participants with anti-drug antibodies to EOS884448
Time Frame
Up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
iTeos Belgium SA
Phone
+32 71 91 99 33
Email
clinical_info@iteostherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iteos Clinical Trials
Organizational Affiliation
iTeos Belgium SA
Official's Role
Study Director
Facility Information:
Facility Name
Hackensack University Medical Center
City
Bergen
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical trials Unit
Facility Name
GZA Ziekenhuizen campus Sint-Augustinus
City
Antwerpen
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Unit
Facility Name
Cliniques universitaires St Luc-UCL
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Unit
Facility Name
Institut de Cancérologie de l'Ouest
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Unit

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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