Vactosertib and Durvalumab in Gastric Cancer

Hark Kyun Kim55 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stomach Neoplasm

Interventions

durvalumab and vactosertibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

Hark K Kim, MD,PhD

CONTACT

+82-31-920-2238 hkim@ncc.re.kr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.