Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-06-15 @ 8:00 PM
Study NCT ID:
NCT03724851
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2018-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vactosertib in Combination with Pembrolizumab in Metastatic Colorectal or Gastric Cancer
Sponsor:
MedPacto, Inc.
Organization:
Study Overview
Official Title:
A Phase 1b/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib in Combination with Pembrolizumab in Patients with Metastatic or Locally Advanced Colorectal or Gastric Cancer/ Gastroesophageal Junction Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, multicenter study to assess the safety, tolerability, pharmacokinetics, and antitumor activity of vactosertib in combination with pembrolizumab in patients with metastatic or locally advanced colorectal or gastric/gastroesophageal junction adenocarcinoma
Detailed Description:
This is phase 1b/2a, open label, multi-center study to assess safety, tolerability, pharmacokinetics and anti-tumor activity of vactosertib in combination with pembrolizumab in patients with mCRC including CMS4 or diffuse GC/GEJC with two phases (Dose Finding Phase and Dose Expansion Phase). At screening, CMS4 will be classified by an experienced pathologist in the central lab that will examine the histology of primary surgical tissues. Approximately, 67 total patients are expected to be enrolled in this study. The first phase of the study, the Dose Finding Phase, will determine the MTD of the combination regimen. The second phase, the Dose Expansion Phase, will further evaluate the combination regimen to confirm RP2D.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Mk3475 Keynote 900 | OTHER | MSD | View |