NCT03724851

Vactosertib in Combination with Pembrolizumab in Metastatic Colorectal or Gastric Cancer

Completed Phase 1, PHASE2 Last updated 25 March 2025

What this trial tests

Phase 1, PHASE2 trial testing TEW-7197 in Metastatic Colorectal Cancer in 120 participants. Completed in 7 May 2024.

Timeline

20 December 2018

Primary endpoint
7 May 2024

7 May 2024

Quick facts

Lead sponsor	MedPacto, Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	20 December 2018
Primary completion	7 May 2024
Estimated completion	7 May 2024
Sites	5 locations across South Korea

Drugs / interventions tested

• TEW-7197 — full drug profile →

Conditions studied

• Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
• Gastric Cancer — all drugs for Gastric Cancer →
• Gastroesophageal Junction Adenocarcinoma — all drugs for Gastroesophageal Junction Adenocarcinoma →

Sponsor

MedPacto, Inc. — full company profile →

Who can join

19 and older, any sex, with Metastatic Colorectal Cancer or Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel therapies emerging in oncology to target the TGF-β pathway.
   Kim BG, Malek E, Choi SH, Ignatz-Hoover JJ, et al · · 2021 · cited 336× · PMID 33823905 · DOI 10.1186/s13045-021-01053-x
2. Targeting TGFβ signal transduction for cancer therapy.
   Liu S, Ren J, Ten Dijke P. · · 2021 · cited 302× · PMID 33414388 · DOI 10.1038/s41392-020-00436-9
3. Exploring immunotherapy in colorectal cancer.
   Weng J, Li S, Zhu Z, Liu Q, et al · · 2022 · cited 250× · PMID 35842707 · DOI 10.1186/s13045-022-01294-4
4. Current and emerging therapeutic approaches for colorectal cancer: A comprehensive review.
   Kumar A, Gautam V, Sandhu A, Rawat K, et al · · 2023 · cited 159× · PMID 37206081 · DOI 10.4240/wjgs.v15.i4.495
5. Dual inhibition of TGF-β and PD-L1: a novel approach to cancer treatment.
   Gulley JL, Schlom J, Barcellos-Hoff MH, Wang XJ, et al · · 2022 · cited 132× · PMID 34854206 · DOI 10.1002/1878-0261.13146
6. Therapeutic Targets for the Treatment of Cardiac Fibrosis and Cancer: Focusing on TGF-β Signaling.
   Parichatikanond W, Luangmonkong T, Mangmool S, Kurose H. · · 2020 · cited 118× · PMID 32211422 · DOI 10.3389/fcvm.2020.00034
7. Blocking TGF-β Signaling To Enhance The Efficacy Of Immune Checkpoint Inhibitor.
   Bai X, Yi M, Jiao Y, Chu Q, et al · · 2019 · cited 115× · PMID 31807028 · DOI 10.2147/ott.s224013
8. TGF-beta signal transduction: biology, function and therapy for diseases.
   Tie Y, Tang F, Peng D, Zhang Y, et al · · 2022 · cited 97× · PMID 36534225 · DOI 10.1186/s43556-022-00109-9