Testing RS-0139 in patients with advanced solid tumors

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

This study is testing a new drug called RS-0139 to see if it is safe and what the best dose is for people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S. (industry)
• Locations: 2 sites (Ankara and 1 other locations)
• Trial ID: NCT04261413 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label study aims to evaluate the safety, pharmacokinetics, and optimal dosing of RS-0139 in patients with recurrent, locally advanced, or metastatic solid tumors. The study is structured in two phases (Ia and Ib) and employs an accelerated titration design to determine the most effective dose. Participants will provide fresh or archival biopsy samples to assess integrin expression levels, which is crucial for the Phase Ib component of the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with relapsed or refractory solid tumors who have failed standard therapies.

Not a fit: Patients with solid tumors that are not recurrent or locally advanced, or those who are candidates for standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with advanced solid tumors who have limited therapeutic alternatives.

How similar studies have performed: Other studies targeting similar patient populations with innovative therapies have shown promise, suggesting potential for success in this approach.

Eligibility criteria

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 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.
* Patients who have bone marrow transplantation history.
* Patients who have hypersensitivity to docetaxel, components of RS-0139 and/or other taxanes.
* Patients taking inhibitors or inducers of CYP3A4, including grapefruit juice and OTC medications such as St. John's Wort.
* Patients who, in the judgment of the PI, are likely to be non-compliant or unable to cooperate.
* Patients who cannot be contacted in case of emergency.
* Patients who are the PI or sub-investigator, research assistant, pharmacist, study coordinator or other staff directly involved in conducting the study.

Where this trial is running

Ankara and 1 other locations

• Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi — Ankara, Turkey (RECRUITING)
• Koç University Hospital Phase I Center — Istanbul, Turkey (RECRUITING)

Study contacts

• Study coordinator: Gulsah Nomak

Conditions: Solid Tumors, solid tumors, chemotherapy, targeted