APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Multiple doses of EOS301984
Multiple doses of EOS301984 in combination with Anti-PD-1
Institut Jules Bordet
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Grand Hopital de Charleroi
Charleroi, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors
Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)
Incidence and severity of AEs in patients receiving EEOS301984
Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)
Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level
Time frame: From first dose up to 21 days repeated cycles
Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level
Time frame: From first dose up to 21 days repeated cycles
Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors.
Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)
Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)
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CHU de Liège
Liège, Belgium
GZA Ziekenhuizen campus Sint-Augustinus
Wilrijk, Belgium