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Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer

NCT05429697 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2022-09-27

No results posted yet for this study

Summary

This study is designed to assess the antitumor activity of combination therapy of SMT-NK (allogeneic natural killer cells) and pembrolizumab versus pembrolizumab monotherapy in patients with advanced biliary tract cancer

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

SMT-NK inj.+Pembrolizumab

SMT-NK inj. will be administered as an intravenous (IV) infusion on Day 1,Day 7 of each 21-day cycle. Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

DRUG

Pembrolizumab

Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

Sponsors & Collaborators

  • SMT bio Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • SEUNGWOO PARK · Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2025-01-08
Completion
2026-06-08

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429697 on ClinicalTrials.gov