Vactosertib in Combination With Pembrolizumab in Metastatic Colorectal or Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT03724851|
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer Gastric Cancer Gastroesophageal Junction Adenocarcinoma||Drug: TEW-7197||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2a Study to Assess the Safety, Tolerability, PK, and Antitumor Activity of Vactosertib in Combination With Pembrolizumab in Patients With Metastatic Colorectal or Gastric Gastroesophageal Junction Adenocarcinoma|
|Actual Study Start Date :||November 28, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||February 2022|
Experimental: Dose Escalation of TEW-7197
TEW-7197 will be administered orally for 5 days per week (5D/W) and Pembrolizumab will be administered as a dose of 200 mg every 3weeks.
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.Pembrolizumab will be administered as a dose of 200 mg every 3weeks.
Other Name: vactosertib
- Maximum Tolerated Dose [ Time Frame: 3weeks ]To define the MTD
- Number of participants with treatment-related adverse events assessed by NCI CTCAE v 5.0 [ 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.
- Efficacy of TEW-7197+Pembrolizumab [ Time Frame: through study completion, an average of 2 years ]Objective Response Rate(%)
- Pharmacokinetics (PK) of TEW-7197 [ Time Frame: At cycle 1(each cycle is 21days) ]Peak Plasma Concentration of TEW-7197
- Pharmacodynamics of TEW-7197 [ Time Frame: At cycle 1 ,3 (each cycle is 21days) ]pSMAD in peripheral blood mononuclear cell determined by immunohistochemistry
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): NCT03724851
|Contact: Kyounghee Kim, BSNemail@example.com|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of, 05505|
|Study Director:||Sunjin Hwang, MD||MedPacto, Inc.|