CClinicalTrials.gg
Sign In
Status unknownNCT04893252Updated Nov 30, 2022

Vactosertib and Durvalumab in Gastric Cancer

A Phase 2 interventional study of durvalumab and vactosertib in Stomach Neoplasm, sponsored by Hark Kyun Kim. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-30.

Sponsored by Hark Kyun Kim · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This trial will test the efficacy and safety of durvalumab in combination with vactosertib in patients with metastatic gastric cancers who failed ≥ 2 lines of chemotherapy

Read the detailed description

Efficacy and safety of durvalumab (anti-PD-L1) via IV infusion Q4W, in combination with vactosertib (TGF-beta inhibitor) PO bid for 5 days a week for up to a maximum of 12 months, will be tested in patients with metastatic hypermutated gastric cancers as ≥ 3rd-line setting until confirmed disease progression, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

02

Conditions studied

  • Stomach Neoplasm

Browse trials for

03

In context

Stomach Neoplasms

2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.

This study's planned enrollment of 55 is below the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

This is the only study on the registry with Hark Kyun Kim as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have histologically- or cytologically-confirmed diagnosis of metastatic gastric adenocarcinoma in the stomach and gastroesophageal junction that are refractory to at least two lines of treatment.
  • Have a performance status of 0-1 on the ECOG Performance Scale.
  • Have measurable disease at least one investigator-assessed measurable disease per RECIST v1.1
  • Have adequate organ functions

Exclusion criteria

Exclusion Criteria:

  • Prior ALK5 inhibitor treatment
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
  • Patients weighing \<30kg
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    vactosertib in combination with durvalumab

    single arm study

    Drug: durvalumab and vactosertib

Interventions

  • Drugdurvalumab and vactosertib

    durvalumab IV Q4W in combination with vactosertib PO bid (5 days a week)

06

What researchers measure

Primary outcomes

  1. Objective response rate

    Objective response rate in 55 participants according to RECIST v1.1

    Time frame: Every 8 weeks from the date of the first dose until the date of progression, assessed up to 1 year

07

Study locations

1 of 1 sites recruiting
  • National Cancer Center
    Goyang, Gyeonggi 10408, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04893252
Lead sponsor
Hark Kyun Kim
Responsible party
Hark Kyun Kim (Principle Investigator, National Cancer Center, Korea) — Sponsor-investigator
First posted
May 19, 2021
Start date
Jun 1, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Nov 30, 2022

Study contacts

Hark K Kim, MD,PhD
Contact
hkim@ncc.re.kr
+82-31-920-2238

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stomach Neoplasms→

Start the discussion