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

NSCLC Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04261413
• Other study ID #: RS-001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 13, 2021
• Est. completion date: August 2024

Study information

• Verified date: December 2022
• Source: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.
• Contact: Gulsah Nomak
• Phone: 00905333020180
• Email: gn[@]rsresearch.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 avß6 (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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• RS-0139
RS-0139 will be administered for the indication of NSCLC.

Locations

Country	Name	City	State
Turkey	Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi	Ankara
Turkey	Koç University Hospital Phase I Center	Istanbul

Sponsors (1)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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