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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 : September 29, 2021
Sponsor:
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 combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.: EOS-448 will be combined with pembrolizumab, a marketed anti-PD-1 antibody in one treatment arm and a second treatment arm will evaluate EOS-448 combined with inupadenant, an investigational adenosine A2A receptor antagonist.

Condition or disease Intervention/treatment Phase
Advanced Cancer Lung Cancer Head and Neck Cancer Melanoma Drug: EOS-448 Drug: Anti-PD1 Drug: inupadenant Phase 1 Phase 2

Detailed Description:

The study will be conducted in multiple staged parts:

  • Part 1 consists of two dose finding cohorts evaluating safety and tolerability as well as determining the recommended phase 2 dose (RP2D) of EOS-448 combined with pembrolizumab (Part 1A) or with inupadenant (Part 1B), in participants with advanced solid tumors.
  • Part 2 is the expansion part of the study. It will further explore the safety, tolerability, anti-tumor activity as well as pharmacokinetics and pharmacodynamics of EOS-448 combined with pembrolizumab in participants with PD-L1 positive first line (1L) mNSCLC (Part 2A and 2B) or in participants with PD-L1 positive 1L mHNSCC (Part 2C and 2D) and, of EOS-448 combined with inupadenant in participants with anti-PD-(L)1 resistant metastatic cutaneous melanoma (Part 2E), treated at the respective combinations RP2D.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 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


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: Anti-PD1
Anti-PD-1 monoclonal antibody
Other Name: pembrolizumab

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




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 ]

Other Outcome Measures:
  1. Change from baseline in absolute cell count in the tumor and in peripheral blood [ Time Frame: Up to 48 weeks ]
  2. Frequency of activation/exhaustion markers in the tumor and in peripheral blood [ Time Frame: Up to 48 weeks ]


Information from the National Library of Medicine

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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 a predicted life expectancy of ≥ 16 weeks
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1.
  • Have adequate organ functions
  • Part 1 : Have histologically or cytologically confirmed advanced or metastatic solid tumor for whom no standard treatment with survival benefit is available
  • Part 2 (lung cancer, H&N) Are eligible to receive pembrolizumab monotherapy in first line (1L) metastatic setting, as standard of care and according to local treatment guidelines.
  • Part 2 (lung cancer, H&N) : 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.

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: Clarisse Truong 0032477892186 clarisse.truong@iteostherapeutics.com
Contact: Olivier De Henau olivier.deheneau@iteostherapeutics.com

Locations
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United States, New Jersey
Hackensack University Medical Center Recruiting
Bergen, New Jersey, United States, 07601
Contact: Dr Martin Gutierrez         
Belgium
GZA Ziekenhuizen campus Sint-Augustinus Recruiting
Antwerpen, Belgium
Contact: Dr Tom Van Den Mooter         
Cliniques universitaires St Luc-UCL Recruiting
Brussels, Belgium
Contact: Dr Jean-Pascal Machiels         
Sponsors and Collaborators
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: September 29, 2021
Last Verified: September 2021
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
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents