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Vactosertib in Combination with Pembrolizumab in Metastatic Colorectal or Gastric Cancer

NCT03724851 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-25

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Minkyu Heo · MedPacto, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2024-05-07
Completion
2024-05-07

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03724851 on ClinicalTrials.gov