Vactosertib and Durvalumab in Gastric Cancer

NCT ID: NCT04893252

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Stomach Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vactosertib in combination with durvalumab

single arm study

Group Type EXPERIMENTAL

durvalumab and vactosertib

Intervention Type DRUG

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

Interventions

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durvalumab and vactosertib

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

Intervention Type DRUG

Eligibility Criteria

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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

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hark Kyun Kim

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hark Kyun Kim

Principle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hark K Kim, MD,PhD

Role: CONTACT

+82-31-920-2238

Facility Contacts

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Hark K Kim, MD,PhD

Role: primary

+82-31-920-2238

Hyegyung Chang, RN

Role: backup

+82-31-920-2233

Other Identifiers

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33737

Identifier Type: -

Identifier Source: org_study_id

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