Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC
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|ClinicalTrials.gov Identifier: NCT04261413|
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : January 19, 2022
|Condition or disease||Intervention/treatment||Phase|
|NSCLC||Drug: RS-0139||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||December 13, 2021|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||January 2023|
There will be only RS-0139 arm in the study.
RS-0139 will be administered for the indication of NSCLC.
- Maximum tolerated dose [ Time Frame: 21 days for Phase Ia and 100 days for Phase Ib ]The maximum tolerated dose and the appropriate dose range of RS-0139 in recurrent, locally advanced or metastatic non-small cell lung cancer patients.
- Dose-limiting toxicities [ Time Frame: 21 days for Phase Ia and 100 days for Phase Ib ]The incidence of dose-limiting toxicities occurring after each dose given to the patients
- Dose reductions or treatment interruptions [ Time Frame: 21 days for Phase Ia and 100 days for Phase Ib ]Dose reductions or treatment interruptions due to the possible adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261413
|Contact: Gulsah Nomakfirstname.lastname@example.org|
|Contact: Sena Nomakemail@example.com|