Clinical trial NCT03873883: First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer
Official title: Phase I/Ib First-in-Human Study of EOS100850 (Inupadenant) As a Single Agent and in Combination with Pembrolizumab And/or Chemotherapy in Participants with Advanced Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor, Adult
Keywords: solid
tumor
advanced cancers
pharmacokinetics
safety
inupadenant
pembrolizumab
chemotherapy
Lead sponsor: iTeos Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: iTeos Belgium SA
name: Merck Sharp & Dohme LLC
First posted: 2019-03-14
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850
timeFrame: During the DLT evaluation period that is cycle 1 (each cycle is 3 or 4 weeks)
measure: Incidence and severity of AEs in patients receiving EOS100850
timeFrame: Up to 30 months
Secondary outcomes:
measure: Plasma concentration of EOS100850 vs. time profiles
timeFrame: Up to 30 months
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to 30 months
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 30 months
measure: Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
timeFrame: Up to 30 months
measure: Plasma concentration half-life (T-HALF)
timeFrame: Up to 30 months
measure: Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Michigan Center
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Hackensack
country: United States
facility: John Theurer Cancer Center, Hackensack University Medical Center
state: New Jersey
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Wilrijk
country: Belgium
facility: Hospital GZA Sint-Augustinus
state: Antwerpen
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
state: Brussels
city: Ghent
country: Belgium
facility: UZ Ghent
state: East-Flanders
city: Brussels
country: Belgium
facility: UCL Saint-Luc
city: Lyon
country: France
facility: Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie- Pôle Régional de Cancérologie
city: Saint-Herblain
country: France
facility: Centre de Lutte Contre le Cancer - Institut de Cancerologie de l&#39;Ouest - Rene Gauducheau
city: Villejuif
country: France
facility: Gustave Roussy
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: St Mary's Hospital, The Catholic University of Korea
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: START Madrid-HM CIOCC Hospital Universitario HM Sanchinarro
city: Pamplona
country: Spain
facility: Universidad de Navarra - Clinica Universitaria de Navarra
city: San Sebastián
country: Spain
facility: Onkologikoa
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
Study officials:
affiliation: iTeos Belgium SA
name: Iteos Clinical Trials
role: STUDY_DIRECTOR
References: