Study of Vactosertib in Combination With Durvalumab in Advanced NSCLC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03732274|
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer Metastatic||Drug: TEW-7197||Phase 1 Phase 2|
This is Phase 1b/2a, open label, multi-center study to assess safety, tolerability, pharmacokinetics and anti-tumor activity of vactosertib in combination with durvalumab in patients advanced NSCLC. This study has been designed to allow for an investigation of the optimal dose of vactosertib in combination with durvalumab. There are two parts to this study: Phase 1b, vactosertib dose-escalation study to determine the recommended phase 2 dose (RP2D) and Phase 2a, non-randomized parallel dose expansion study to confirm RP2D.
In the current dose-escalation (Phase 1b) study to determine RP2D, vactosertib dosing will begin at 100 mg BID for 5 days per week in combination with durvalumab 1500 mg, Q4W. According to the following dose escalation rule, 200 mg BID oral dose as maximum administered dose (MAD) will be administered in combination with durvalumab.
This phase 2a study is a study designed to evaluate the anti-tumor effects of vactosertib in combination with durvalumab in a total of 45 patients with PD-L1 positive advanced NSCLC who progressed following platinum-based chemotherapy (no prior immunotherapy)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib in Combination With Durvalumab in Patients With Advanced Non-Small Cell Lung Cancer|
|Actual Study Start Date :||December 21, 2018|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: Dose Escalation of TEW-7197
TEW-7197 will be administered orally for 5 days per week (5D/W) and Durvalumab administration.
TEW-7197 will be administered orally for 5 days per week (5D/W) at the same time in the morning and evening (BID) approximately 12 hours apart. Durvalumab will be administered as a dose of 1500 mg every 4weeks.
Other Name: vactosetib
- Maximum Tolerated Dose [ Time Frame: 4 weeks ]To define the MTD
- Number of participants with treatment -related adverse events [ Time Frame: From screening through study completion (up to 28 days after the last dose of Investigational Drug ]To evaluate safety profile of TEW-7197 with regards to frequency, type,grade and seriousness and causality of treatment-related clinical and laboratory adverse events
- Objective Response Rate (%) [ Time Frame: every 2 cycles (each cycle is 28 days) and end of treatment (EOT) time point ,EOT is defined as within 30 days from the last dose of study medication by the protocol ]ORR of TEW-7197 in combination with durvalumab by RECIST v1.1
- Pharmacokinetics (PK) of TEW-7197 [ Time Frame: At cycle 1 (each cycle is 28 days) ]Peak Plasma Concentration of TEW-7197
- Pharmadynamics of TEW-7197 [ Time Frame: At cycle 1 ,3 (each cycle is 28days) ]Circulating cytokines including TGF-β1, PAI-1
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): NCT03732274
|Contact: Kyounghee Kim, BSNemail@example.com|
|Contact: Sunjin Hwang, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Yeonsei University Hospotal||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Byoung Chul Cho, PHD 82-10-5212-8867 CBC1971@yuhs.ac|
|Study Director:||Sunjin Hwang, MD||MedPacto, Inc.|