NCT04835896

Study of M7824 and Paclitaxel Combination as a Second-line Treatment in Patients With Recurrent/Metastatic Gastric Cancer

Completed Phase 1, PHASE2 Last updated 6 May 2024

What this trial tests

Phase 1, PHASE2 trial testing M7824+paclitaxel in Recurrent/Metastatic Gastric Cancer in 49 participants. Completed in 27 October 2023.

Timeline

2 June 2021

Primary endpoint
27 October 2023

27 October 2023

Quick facts

Lead sponsor	Yonsei University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	2 June 2021
Primary completion	27 October 2023
Estimated completion	27 October 2023
Sites	1 location across South Korea

Drugs / interventions tested

• M7824+paclitaxel — full drug profile →

Conditions studied

• Recurrent/Metastatic Gastric Cancer — all drugs for Recurrent/Metastatic Gastric Cancer →

Sponsor

Yonsei University

Who can join

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

Sponsor's own description

This is a Phase 1b/2 study to identify the recommended dose of M7824 for further study with weekly paclitaxel, and to assess the safety and clinical efficacy of this combined treatment in advanced gastric cancer after first line treatment. The study will be conducted in two parts: Part 1 (Phase 1b) dose escalation study to determine the MTD and RP2D of weekly paclitaxel in combination with fixed dose M7824, Part 2 (Phase 2) to further evaluate the safety and tolerability of the combination of M7824 and paclitaxel at the RP2D and determine anti-tumor activity.

Publications & conference data

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

1. Targeting cytokine and chemokine signaling pathways for cancer therapy.
   Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
2. The difficulty in translating the preclinical success of combined TGFβ and immune checkpoint inhibition to clinical trial.
   Metropulos AE, Munshi HG, Principe DR. · · 2022 · cited 59× · PMID 36455409 · DOI 10.1016/j.ebiom.2022.104380
3. Tumor in the Crossfire: Inhibiting TGF-β to Enhance Cancer Immunotherapy.
   Tschernia NP, Gulley JL. · · 2022 · cited 45× · PMID 35353346 · DOI 10.1007/s40259-022-00521-1
4. Engineered antibody fusion proteins for targeted disease therapy.
   Silver AB, Leonard EK, Gould JR, Spangler JB. · · 2021 · cited 40× · PMID 34706833 · DOI 10.1016/j.tips.2021.09.009
5. Macrophage and monocyte subsets as new therapeutic targets in cancer immunotherapy.
   Fendl B, Berghoff AS, Preusser M, Maier B. · · 2023 · cited 34× · PMID 36731326 · DOI 10.1016/j.esmoop.2022.100776
6. Targeting transforming growth factor beta signaling in metastatic osteosarcoma.
   Ge R, Huang GM. · · 2023 · cited 25× · PMID 38021074 · DOI 10.1016/j.jbo.2023.100513
7. Biological and Clinical Aspects of Metastatic Spinal Tumors.
   Litak J, Czyżewski W, Szymoniuk M, Sakwa L, et al · · 2022 · cited 17× · PMID 36230523 · DOI 10.3390/cancers14194599
8. Gastric Cancer and the Immune System: The Key to Improving Outcomes?
   Keshavjee SH, Moy RH, Reiner SL, Ryeom SW, et al · · 2022 · cited 12× · PMID 36497422 · DOI 10.3390/cancers14235940