Vactosertib and Durvalumab in Gastric Cancer

Vactosertib in Combination With Durvalumab (MEDI4736) in Patients With Gastric Cancer

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.

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