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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
Oral administration
IV Infusion
Standard of Care IV Infusion
Karmanos Cancer Institute
Michigan Center, Michigan, United States
John Theurer Cancer Center, Hackensack University Medical Center
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
Time frame: During the DLT evaluation period that is cycle 1 (each cycle is 3 or 4 weeks)
Incidence and severity of AEs in patients receiving EOS100850
To assess safety and tolerability as measured by incidence and severity of AEs
Time frame: Up to 30 months
Plasma concentration of EOS100850 vs. time profiles
Determined by inspection of the concentration-time profile
Time frame: Up to 30 months
Maximum observed serum concentration (Cmax)
Determined by inspection of the concentration-time profile
Time frame: Up to 30 months
Time of maximum observed concentration (Tmax)
Determined by inspection of the concentration-time profile
Time frame: Up to 30 months
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
Determined by inspection of the concentration-time profile
Time frame: Up to 30 months
Plasma concentration half-life (T-HALF)
Determined by inspection of the concentration-time profile
Time frame: Up to 30 months
Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
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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 Capital, Belgium
UCL Saint-Luc
Brussels, Brussels Capital, Belgium
UZ Ghent
Ghent, East-Flanders, 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
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
Saint-Herblain, France
...and 9 more locations
Assessment of preliminary efficacy of EOS100850
Time frame: Up to 30 months