Vactosertib in Combination with Pembrolizumab in Metastatic Colorectal or Gastric Cancer

Phase 1

Completed

• Conditions: Metastatic Colorectal Cancer; Gastroesophageal Junction Adenocarcinoma; Gastric Cancer
• Interventions: Drug: TEW-7197

• Registration Number: NCT03724851
• Lead Sponsor: MedPacto, Inc.

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 Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-28
• Study First Posted: 2018-10-30
• Study Start: 2018-12-20
• Primary Completion: 2024-05-07
• Study Completion: 2024-05-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Expansion (300mg BID)	TEW-7197	TEW-7197 300mg BID, 5D/W + Pembrolizumab 200mg Q3W (n= 30)
Dose Expansion (200mg QD)	TEW-7197	TEW-7197 200mg QD, 5D/W + Pembrolizumab 200mg Q3W (n= 30)
Dose Expansion (200mg BID)	TEW-7197	TEW-7197 200mg BID, 5D/W + Pembrolizumab 200mg Q3W (n= 30)

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	approximately 2 years	Incidence, nature and severity of adverse events (AEs) graded according to NCI CTCAE v5.0
Maximum Tolerated Dose	approximately 2 years	Incidence of nature of DLTs

Secondary Outcome Measures

Name	Time	Method
Efficacy 3	up to 3 years	Overall Survival (OS)
Efficacy 1	approximately 2 years	Objective response rate (ORR) as assessed using RECIST version 1.1 and iRECIST by investigators
Efficacy 2	approximately 2 years	Progression Free Survival (PFS)

Trial Locations

Locations (5)

Yeonsei University Hospital; 🇰🇷 Seoul, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of