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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.

Criteria

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 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.