Stomach Neoplasm
Conditions
Brief 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
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.
Interventions
DRUGdurvalumab and vactosertib
durvalumab IV Q4W in combination with vactosertib PO bid (5 days a week)
Sponsors
Hark Kyun Kim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* Prior ALK5 inhibitor treatment * Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs * Patients weighing \<30kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Every 8 weeks from the date of the first dose until the date of progression, assessed up to 1 year | Objective response rate in 55 participants according to RECIST v1.1 |
Countries
South Korea
Contacts
Primary ContactHark K Kim, MD,PhD
Outcome results
None listed