First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer
NCT ID: NCT03873883
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
119 participants
INTERVENTIONAL
2019-02-05
2024-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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1A Dose escalation EOS100850
Dose Escalation- EOS100850 Monotherapy: to confirm RP2D
EOS100850
Oral administration
1B Dose escalation EOS100850 and Pembrolizumab
EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination
EOS100850
Oral administration
Pembrolizumab
IV Infusion
2A Dose Expansion- EOS100850
Dose Expansion - EOS100850 Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy
EOS100850
Oral administration
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
EOS100850
Oral administration
Pembrolizumab
IV Infusion
2D Dose expansion - EOS100850 and Chemotherapy in TNBC
Dose expansion - EOS100850 and Chemotherapy Combination: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with chemotherapy SOC carboplatin and paclitaxel in patients with TNBC
EOS100850
Oral administration
Chemotherapy
Standard of Care IV Infusion
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
EOS100850
Oral administration
Interventions
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EOS100850
Oral administration
Pembrolizumab
IV Infusion
Chemotherapy
Standard of Care IV Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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iTeos Belgium SA
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
iTeos Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Iteos Clinical Trials
Role: STUDY_DIRECTOR
iTeos Belgium SA
Locations
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Karmanos Cancer Institute
Michigan Center, Michigan, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Hospital GZA Sint-Augustinus
Wilrijk, Antwerpen, Belgium
Institut Jules Bordet
Anderlecht, Brussels Capital, Belgium
UCL Saint-Luc
Brussels, Brussels Capital, Belgium
UZ Ghent
Ghent, East-Flanders, Belgium
Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
Lyon, , France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie- Pôle Régional de Cancérologie
Poitiers, , France
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
Saint-Herblain, , France
Gustave Roussy
Villejuif, , France
Yonsei University Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
St Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Hospital del Mar
Barcelona, , Spain
START Madrid-HM CIOCC Hospital Universitario HM Sanchinarro
Madrid, , Spain
Universidad de Navarra - Clinica Universitaria de Navarra
Pamplona, , Spain
Onkologikoa
San Sebastián, , Spain
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Other Identifiers
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2018-003173-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Keynote A45
Identifier Type: OTHER
Identifier Source: secondary_id
IO-001
Identifier Type: -
Identifier Source: org_study_id
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