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

December 20, 2023 updated by: iTeos Therapeutics

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • UCL Saint-Luc
      • Brussels, Belgium, 1070
        • Institut Jules Bordet
      • Ghent, Belgium, 9000
        • UZ Ghent
    • Antwerp
      • Wilrijk, Antwerp, Belgium, 2610
        • Hospital GZA Sint-Augustinus
  • France
      • Lyon, France, 69008
        • Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
      • Poitiers, France, 86021
        • Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie- Pôle Régional de Cancérologie
      • Saint-Herblain, France, 44805
        • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
      • Villejuif, France, 94805
        • Gustave Roussy
  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Severance Hospital
      • Seoul, Korea, Republic of, 06591
        • St Mary's Hospital, The Catholic University of Korea
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Madrid, Spain, 28050
        • START Madrid-HM CIOCC Hospital Universitario HM Sanchinarro
      • Pamplona, Spain, 31008
        • Universidad de Navarra - Clinica Universitaria de Navarra
      • San Sebastián, Spain, 20014
        • Onkologikoa
  • United Kingdom
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
  • United States
    • Michigan
      • Michigan Center, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center, Hackensack University Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1A Dose escalation EOS100850
Dose Escalation- EOS100850 Monotherapy: to confirm RP2D
Drug: EOS100850
Oral administration
Experimental: 1B Dose escalation EOS100850 and Pembrolizumab
EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination
Drug: Pembrolizumab
IV Infusion
Other Names:
  • Keytruda
  • MK-3475
Drug: EOS100850
Oral administration
Experimental: 2A Dose Expansion- EOS100850
Dose Expansion- Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy
Drug: EOS100850
Oral administration
Experimental: 2B Dose Expansion - EOS100850 and Pembrolizumab
Dose Expansion - EOS100850 and Pembrolizumab Combination Therapy: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with pembrolizumab in melanoma and CRPC patients
Drug: Pembrolizumab
IV Infusion
Other Names:
  • Keytruda
  • MK-3475
Drug: EOS100850
Oral administration
Experimental: 2D Dose expansion - EOS100850 and Chemotherapy in TNBC
Dose expansion - EOS100850 and Chemotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with chemotherapy SOC carboplatin and paclitaxel in patients with TNBC
Drug: EOS100850
Oral administration
Drug: Chemotherapy
Standard of Care
Other Names:
  • carboplatin and paclitaxel
Experimental: 3 EOS100850 in BMK-H participants
Dose expansion - EOS100850 Monotherapy : to evaluate the safety, PD, and antitumor activity of inupadenant as monotherapy at the mono-RP2D in BMK-H participants in 4 disease-specific cohorts: NSCLC; HNSCC; EC; and other forms of cancer
Drug: EOS100850
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 15 months
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
Up to 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentration of EOS100850 vs. time profiles
Time Frame: Up to 15 months
Determined by inspection of the concentration-time profile
Up to 15 months
Maximum observed serum concentration (Cmax)
Time Frame: Up to 15 months
Determined by inspection of the concentration-time profile
Up to 15 months
Time of maximum observed concentration (Tmax)
Time Frame: Up to 15 months
Determined by inspection of the concentration-time profile
Up to 15 months
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
Up to 15 month
Plasma concentration half-life (T-HALF)
Time Frame: Up to 15 month
Determined by inspection of the concentration-time profile
Up to 15 month
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
Up to 15 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iTeos Therapeutics

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Actual)

June 23, 2023

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IO-001
  • Keynote A45 (Other Identifier: Merck and Co.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solid Tumor, Adult

Clinical Trials on Pembrolizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe