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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03873883
• Other study ID #: IO-001
• Secondary ID: Keynote A45
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 28, 2019
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: iTeos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Drug:
• EOS100850
Oral administration
• Pembrolizumab
IV Infusion
• Chemotherapy
Standard of Care

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
iTeos Therapeutics	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Belgium,  France,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

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