NCT03724851

Vactosertib in Combination with Pembrolizumab in Metastatic Colorectal or Gastric Cancer

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: MedPacto, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	TEW-7197	Vactosertib will be administered orally without regard to meals for 5 days per week (5D/W) at the same time in the morning (QD), at the same time in the morning and evening (BID) approximately 12 hours apart. Pembrolizumab will be administered as a dose of 200 mg using a 30-minute IV infusion. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible.

Timeline

• Start date: 2018-12-20
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2018-10-30
• Last updated: 2025-03-25

Locations

5 sites across 1 country: South Korea