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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04893252
Other study ID # 33737
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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