Solid Tumor, Adult Clinical Trial
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
Verified date | December 2023 |
Source | iTeos Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 119 |
Est. completion date | July 2024 |
Est. primary completion date | June 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Institut Jules Bordet | Brussels | |
Belgium | UCL Saint-Luc | Brussels | |
Belgium | UZ Ghent | Ghent | |
Belgium | Hospital GZA Sint-Augustinus | Wilrijk | Antwerp |
France | 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 | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | St Mary's Hospital, The Catholic University of Korea | Seoul | |
Korea, Republic of | Yonsei University Severance Hospital | Seoul | |
Spain | 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 | |
United Kingdom | The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital | Sutton | |
United States | John Theurer Cancer Center, Hackensack University Medical Center | Hackensack | New Jersey |
United States | Karmanos Cancer Institute | Michigan Center | Michigan |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
iTeos Therapeutics | Merck Sharp & Dohme LLC |
United States, Belgium, France, Korea, Republic of, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850 | To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850 | Up to 15 months | |
Primary | Incidence and severity of AEs in patients receiving EOS100850 | To assess safety and tolerability as measured by incidence and severity of AEs | Up to 15 months | |
Secondary | Plasma concentration of EOS100850 vs. time profiles | Determined by inspection of the concentration-time profile | Up to 15 months | |
Secondary | Maximum observed serum concentration (Cmax) | Determined by inspection of the concentration-time profile | Up to 15 months | |
Secondary | Time of maximum observed concentration (Tmax) | Determined by inspection of the concentration-time profile | Up to 15 months | |
Secondary | Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] | Determined by inspection of the concentration-time profile | Up to 15 month | |
Secondary | Plasma concentration half-life (T-HALF) | Determined by inspection of the concentration-time profile | Up to 15 month | |
Secondary | Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 | Assessment of preliminary efficacy of EOS100850 | Up to 15 month |
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---|---|---|---|
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