This study designed as a multicenter, open label, two-step study to determine the optimum dose, pharmacokinetics, and the safety of RS-0139 in patients with a recurrent, locally advanced or metastatic solid tumors. The research is planned as a two-step study (Phase Ia and phase Ib) and accelerated titration design (ATD) is used.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
RS-0139 will be administered for the indication of solid tumors.
Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
Ankara, Turkey (Türkiye)
RECRUITINGKoç University Hospital Phase I Center
Istanbul, Turkey (Türkiye)
RECRUITINGDose-limiting toxicities (DLTs)
Time frame: At the end of each cycle (Each cycle is 21 days)
The incidence of AEs, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs).
Time frame: At the end of each cycle (Each cycle is 21 days)
Anti-tumor activity measured by tumor shrinkage (based on CT-scan evaluations)
Time frame: At the end of Phase Ib (assessed up to 1 year)
Change in CA 125 / CA15-3 / CA 19-9 / CA 72-4 (depends on the tumor type)
Time frame: At the end of Phase Ib (assessed up to 1 year)
Change in circulating tumor cells
Time frame: At the end of Phase Ib (assessed up to 1 year)
Objective Response Rate (ORR)
Time frame: At the end of Phase Ib (assessed up to 1 year)
Progression-Free Survival (PFS)
Time frame: At the end of Phase Ib (assessed up to 1 year)
Duration of Response (DoR)
Time frame: At the end of Phase Ib (assessed up to 1 year)
Peak plasma concentration (Cmax)
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
AUC(o-t)
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC(0-∞)
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
tmax
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
t1/2
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
λz
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
CL
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
Vss
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)