Vactosertib and Durvalumab in Gastric Cancer

Hark Kyun Kim

Status and phase: Enrolling; Phase 2

Conditions: Stomach Neoplasm

Treatments: Drug: durvalumab and vactosertib

Study type: Interventional

Funder types: Other

Identifiers

NCT04893252

33737

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

vactosertib in combination with durvalumab

Experimental group

Description:

single arm study

Treatment:

Drug: durvalumab and vactosertib