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First-in-Human Study of EOS100850 in Patients With Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03873883
Recruitment Status : Active, not recruiting
First Posted : March 14, 2019
Last Update Posted : April 28, 2023
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
iTeos Therapeutics

Study Description
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Brief Summary:
Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: EOS100850 Drug: Pembrolizumab Drug: Chemotherapy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/Ib First-in-Human Study of EOS100850 as a Single Agent and in Combination With Pembrolizumab and/or Chemotherapy in Participants With Advanced Cancers
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation- Monotherapy
Specified dose on specified days
 Drug: EOS100850
Oral administration
Experimental: EOS100850 and Pembrolizumab Combination Therapy
Specified dose on specified days
 Drug: EOS100850
Oral administration

Drug: Pembrolizumab
IV Infusion
Other Names:
  • Keytruda
  • MK-3475
Experimental: EOS100850 and SOC Combination Chemotherapy
Specified EOS100850 dose on specified days
 Drug: EOS100850
Oral administration

Drug: Chemotherapy
Standard of Care


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850 [ Time Frame: Up to 15 months ]
    To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850

  2. Incidence and severity of AEs in patients receiving EOS100850 [ Time Frame: Up to 15 months ]
    To assess safety and tolerability as measured by incidence and severity of AEs


Secondary Outcome Measures :
  1. Plasma concentration of EOS100850 vs. time profiles [ Time Frame: Up to 15 months ]
    Determined by inspection of the concentration-time profile

  2. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 15 months ]
    Determined by inspection of the concentration-time profile

  3. Time of maximum observed concentration (Tmax) [ Time Frame: Up to 15 months ]
    Determined by inspection of the concentration-time profile

  4. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 15 month ]
    Determined by inspection of the concentration-time profile

  5. Plasma concentration half-life (T-HALF) [ Time Frame: Up to 15 month ]
    Determined by inspection of the concentration-time profile

  6. Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 15 month ]
    Assessment of preliminary efficacy of EOS100850


Eligibility Criteria
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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

For more information regarding participation in the Trial, please refer to your physician

Inclusion Criteria:

  • Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available.
  • At least 4 weeks since any previous treatment for cancer
  • Subject must consent to pretreatment and on treatment tumor biopsies
  • Adequate organ and marrow function

Exclusion Criteria:

  • Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
  • Participants with second/other active cancers requiring current treatment
  • Uncontrolled/significant heart disease
  • Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
  • Active/uncontrolled autoimmune disease
  • Active infection

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
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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): NCT03873883


Locations
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United States, New Jersey
Research Site
Hackensack, New Jersey, United States, 07601
Belgium
Research Site
Brussels, Belgium, 1000
Research Site
Brussels, Belgium, 1200
Research Site
Ghent, Belgium, 9000
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
iTeos Therapeutics
Merck Sharp & Dohme LLC
More Information
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Responsible Party: iTeos Therapeutics
ClinicalTrials.gov Identifier: NCT03873883    
Other Study ID Numbers: IO-001
Keynote A45 ( Other Identifier: Merck and Co. )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: April 28, 2023
Last Verified: April 2023

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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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Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action