Vactosertib and Durvalumab in Gastric Cancer

Stomach Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893252
• Other study ID #: 33737
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: National Cancer Center, Korea
• Contact: Hark K Kim, MD,PhD
• Phone: +82-31-920-2238
• Email: hkim[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Drug:
• durvalumab and vactosertib
durvalumab IV Q4W in combination with vactosertib PO bid (5 days a week)

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Hark Kyun Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Objective response rate in 55 participants according to RECIST v1.1	Every 8 weeks from the date of the first dose until the date of progression, assessed up to 1 year