RecruitingPhase 2Phase 3NCT05429697

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

Randomized, Placebo-controlled, Open-label, Phase 2b Clinical Trial to Evaluate the Antitumor Activity of Combination Therapy of SMT-NK and Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer


Sponsor

SMT bio Co., Ltd.

Enrollment

128 participants

Start Date

Jun 9, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a combination treatment — SMT-NK (a type of natural killer cell therapy) plus pembrolizumab (immunotherapy) — against pembrolizumab alone in patients with advanced biliary tract cancer (cancers of the bile ducts or gallbladder) that has not responded to chemotherapy or where chemotherapy is too toxic. **You may be eligible if:** - You are between 19 and 80 years old - You have advanced biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or gallbladder cancer) confirmed by biopsy - Your cancer has not responded to or you cannot tolerate chemotherapy - Your cancer is measurable on scans - Your general health is adequate (ECOG ≤2) - You are expected to survive at least 3 months **You may NOT be eligible if:** - You have a resectable tumor (surgery is still an option) - Your organ function (blood, kidneys, liver) does not meet the required minimums - You are not expected to survive 3 months or more Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSMT-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.

DRUGPembrolizumab

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


Locations(3)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Severance Hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT05429697


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