Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC

Study Overview
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Brief Summary
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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 non-small cell lung cancer (NSCLC). The research is planned as a two-step study (Phase Ia and phase Ib) and accelerated titration design (ATD) is used.

Official Title
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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 Non-small Cell Lung Cancer (NSCLC)

Conditions
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NSCLC

Intervention / Treatment
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* Drug: RS-0139


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have consented for the participation to the trial. Patients of both sexes aged between 18-75 years. Patients who have biopsy material prior to the participation in order to confirm the expression of integrin αvβ6 (for Phase Ib only). Patients with stage IIIB or IV NSCLC and measurable disease by Response Evaluation Criteria in Solid Tumors and availability of at least one measurable tumor focus under RECIST v.1.1 criteria. Patients with NSCLC who progressed after standard therapy options consisting of chemotherapy and/or immunotherapy. 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 0-1 Patients with the following laboratory results: 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 who have active and/or uncontrolled central nervous system (CNS) metastasis. Patients who have pulmonary carcinosarcoma. Patients who have presence of small cell lung cancer components. Patients who have interstitial lung disease or interstitial pneumonia. Patients who have cavitary lung lesions. Patients who have serious cardiac dysfunction. Patients who have insufficient target organ function. Patients who experienced Grade 3 or higher toxicity related to the previous docetaxel treatment. Patients who are pregnant or breastfeeding. Patients who are enrolled in a clinical trial. Patients who have serious medical conditions such as uncontrolled infection or untreated wound. Patients who have bone marrow transplantation history. Patients who have hypersensitivity to docetaxel and/or similar medicines. Patients who, in the judgment of the Investigator, are likely to be non-compliant or unable to cooperate. Patients who cannot be contacted in case of emergency. Patients who are the investigator or sub-investigator, research assistant, pharmacist, study coordinator or other staff directly involved in conducting the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RS-0139<br>There will be only RS-0139 arm in the study. | Drug: RS-0139<br>* RS-0139 will be administered for the indication of NSCLC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose | The maximum tolerated dose and the appropriate dose range of RS-0139 in recurrent, locally advanced or metastatic non-small cell lung cancer patients. | 21 days for Phase Ia and 100 days for Phase Ib | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicities | The incidence of dose-limiting toxicities occurring after each dose given to the patients | 21 days for Phase Ia and 100 days for Phase Ib | 
| Dose reductions or treatment interruptions | Dose reductions or treatment interruptions due to the possible adverse events | 21 days for Phase Ia and 100 days for Phase Ib | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, chemotherapy, targeted therapy