First-in-Human Study of EOS100850 in Patients With Cancer
- Conditions
- Solid Tumor, Adult
- Interventions
- Registration Number
- NCT03873883
- Lead Sponsor
- iTeos Therapeutics
- 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 as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 119
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1A Dose escalation EOS100850 EOS100850 Dose Escalation- EOS100850 Monotherapy: to confirm RP2D 1B Dose escalation EOS100850 and Pembrolizumab EOS100850 EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination 1B Dose escalation EOS100850 and Pembrolizumab Pembrolizumab EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination 2A Dose Expansion- EOS100850 EOS100850 Dose Expansion - EOS100850 Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy 2B Dose Expansion - EOS100850 and Pembrolizumab EOS100850 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 2B Dose Expansion - EOS100850 and Pembrolizumab 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 2D Dose expansion - EOS100850 and Chemotherapy in TNBC EOS100850 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 2D Dose expansion - EOS100850 and Chemotherapy in TNBC Chemotherapy 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 3 EOS100850 in BMK-H participants EOS100850 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
- Primary Outcome Measures
Name Time Method Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850 During the DLT evaluation period that is cycle 1 (each cycle is 3 or 4 weeks) To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850
Incidence and severity of AEs in patients receiving EOS100850 Up to 30 months To assess safety and tolerability as measured by incidence and severity of AEs
- Secondary Outcome Measures
Name Time Method Plasma concentration of EOS100850 vs. time profiles Up to 30 months Determined by inspection of the concentration-time profile
Maximum observed serum concentration (Cmax) Up to 30 months Determined by inspection of the concentration-time profile
Time of maximum observed concentration (Tmax) Up to 30 months Determined by inspection of the concentration-time profile
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] Up to 30 months Determined by inspection of the concentration-time profile
Plasma concentration half-life (T-HALF) Up to 30 months Determined by inspection of the concentration-time profile
Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Up to 30 months Assessment of preliminary efficacy of EOS100850
Trial Locations
- Locations (19)
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
🇫🇷Saint-Herblain, France
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, Belgium
UZ Ghent
🇧🇪Ghent, East-Flanders, Belgium
UCL Saint-Luc
🇧🇪Brussels, 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
Gustave Roussy
🇫🇷Villejuif, France
Yonsei University Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
St Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
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