A Multicenter, Open Label, Two-step, Phase Ia/Ib Study of Tumor Targeted Prodrug RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic Solid Tumors

RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.2 个研究点分布在 1 个国家目标入组 16 人2021年12月13日

适应症Solid Tumors

干预措施RS-0139

概览

阶段: 1 期
干预措施: RS-0139
疾病 / 适应症: Solid Tumors
发起方: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.
入组人数: 16
试验地点: 2
主要终点: Dose-limiting toxicities (DLTs)
状态: 已完成
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2021年12月13日

结束日期

2026年3月4日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.

责任方

Sponsor

入排标准

入选标准

•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
•Patients with adequate organ function defined as:
•Hemoglobin ≥10 mg/dl
•Neutrophil ≥1,500/µL

排除标准

•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 the previous docetaxel treatment.
•Female patients who are pregnant or breastfeeding.
•Male patients with pregnant female partners.
•Patients enrolled in another clinical trial at the same time or recently completed an investigational drug study and received the last dose of an investigational drug within 30 days or five half-lives (whichever is longer).
•Patients who have serious medical conditions such as uncontrolled infection or untreated wounds.

研究组 & 干预措施

RS-0139

There will be only RS-0139 arm in the study.

干预措施: RS-0139

结局指标

主要结局

Dose-limiting toxicities (DLTs)

时间窗: 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).

时间窗: At the end of each cycle (Each cycle is 21 days)

次要结局

Anti-tumor activity measured by tumor shrinkage (based on CT-scan evaluations)(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)(At the end of Phase Ib (assessed up to 1 year))
Change in circulating tumor cells(At the end of Phase Ib (assessed up to 1 year))
Objective Response Rate (ORR)(At the end of Phase Ib (assessed up to 1 year))
Progression-Free Survival (PFS)(At the end of Phase Ib (assessed up to 1 year))
Duration of Response (DoR)(At the end of Phase Ib (assessed up to 1 year))
Peak plasma concentration (Cmax)(At the end of the Phase Ia and Ib (assessed up to 1 year))
AUC(o-t)(At the end of the Phase Ia and Ib (assessed up to 1 year))
AUC(0-∞)(At the end of the Phase Ia and Ib (assessed up to 1 year))
tmax(At the end of the Phase Ia and Ib (assessed up to 1 year))
t1/2(At the end of the Phase Ia and Ib (assessed up to 1 year))
λz(At the end of the Phase Ia and Ib (assessed up to 1 year))
CL(At the end of the Phase Ia and Ib (assessed up to 1 year))
Vss(At the end of the Phase Ia and Ib (assessed up to 1 year))