Vactosertib and Durvalumab in Gastric Cancer
- Registration Number
- NCT04893252
- Lead Sponsor
- Hark Kyun Kim
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 55
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description vactosertib in combination with durvalumab durvalumab and vactosertib single arm study
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Cancer Center
🇰🇷Goyang, Gyeonggi, Korea, Republic of