Status:
UNKNOWN
Vactosertib and Durvalumab in Gastric Cancer
Lead Sponsor:
Hark Kyun Kim
Conditions:
Stomach Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pa...
Eligibility Criteria
Inclusion
- 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
- Prior ALK5 inhibitor treatment
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
- Patients weighing \<30kg
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04893252
Start Date
June 1 2021
End Date
December 31 2023
Last Update
November 30 2022
Active Locations (1)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 10408