Status:
COMPLETED
First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer
Lead Sponsor:
iTeos Therapeutics
Collaborating Sponsors:
iTeos Belgium SA
Merck Sharp & Dohme LLC
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 EOS100...
Eligibility Criteria
Inclusion
- For more information regarding participation in the Trial, please refer to your physician
- 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
- 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
Key Trial Info
Start Date :
February 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03873883
Start Date
February 5 2019
End Date
May 28 2024
Last Update
September 19 2024
Active Locations (19)
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1
Karmanos Cancer Institute
Michigan Center, Michigan, United States, 48201
2
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
3
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
4
Hospital GZA Sint-Augustinus
Wilrijk, Antwerpen, Belgium, 2610