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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who have consented to participation in the trial.
* Patients of both sexes aged between 18 and 75 years.
* Patients with relapsed or refractory solid tumors who have failed available standard therapy or are not candidates for standard therapy.
* Patients who are willing to provide fresh or archival biopsy material before their participation to identify the integrin expression levels (for Phase Ib only).
* Patients who completed the previous treatments 21 days before the first dose of the study drug.
* Patients who have at least three months of life expectancy.
* Patients with ECOG performance score 0 to 1.
* Patients with adequate organ function defined as:
* Hemoglobin ≥10 mg/dl
* Neutrophil ≥1,500/µL
* Platelet ≥100,000/µL
* Creatinine ≤1.5xULN or creatinine clearance ≥60mL/sec/1.73m2
* Total bilirubin ≤ 1.5xULN
* AST/ALT ≤2.5xULN; for patients who have confirmed liver metastasis: AST/ALT ≤5xULN.
* Prothrombin time ≤1.5xULN (in case of no anticoagulant treatment).
* Normal levels of serum magnesium and potassium concentrations
Exclusion Criteria:
* Patients with active and/or uncontrolled central nervous system (CNS) metastasis.
* Patients who have interstitial lung disease or interstitial pneumonia.
* Patients who have serious cardiac dysfunction.
* Patients who have insufficient target organ function.
* Patients with positive tests for HAV, HBV, HCV or HIV.
* Patients who experienced grade 3 or higher toxicity related to …
What they're measuring
1
Dose-limiting toxicities (DLTs)
Timeframe: At the end of each cycle (Each cycle is 21 days)
2
The incidence of AEs, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs).
Timeframe: At the end of each cycle (Each cycle is 21 days)
Trial details
NCT IDNCT04261413
SponsorRS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.