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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: RS-0139

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gulsah Nomak; Phone Number: 00905333020180; Email: gn@rsresearch.net
• Study Contact Backup: Name: Sena Nomak; Phone Number: 00905307606762; Email: sn@rsresearch.net

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
    • Contact: Ozturk Ates; Email: dr.ozturkates@gmail.com
  • Istanbul, Turkey
    • Recruiting
    • Koç University Hospital Phase I Center
    • Contact: Hakan S Orer; Email: horer@ku.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer, chemotherapy, targeted therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: RS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No