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

NCT05429697 | Recruiting Phase 2

• 1 other identifier: SNK-SIT-03
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

BTC; Cholangiocarcinoma; Biliary tract cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression-free survival (PFS) is defined as the time from the date of initial administration of the clinical trial drug to the progression or death due to any cause of the disease

  Up to approximately 72 weeks from the date of first administration of clinical trial drugs

Secondary Outcomes (8)

• Object Response rate

  Up to approximately 72 weeks from the date of first administration of clinical trial drugs

• Time to Progression

  Up to approximately 72 weeks from the date of first administration of clinical trial drugs

• Overall Survival

  Up to approximately 120 weeks from the date of first administration of clinical trial drugs

• Duration of Response

  Up to approximately 72 weeks from the date of first administration of clinical trial drugs

• Disease Control Rate

  Up to approximately 72 weeks from the date of first administration of clinical trial drugs

Study Arms (2)

Pembrolizumab+SMT-NK inj.

EXPERIMENTAL

Experimental: Pembrolizumab + SMT-NK inj. Participants will be randomized to receive 200 mg pembrolizumab followed by 3\*10\^6cells/kg SMT-NK inj. Interventions: Drug: SMT-NK inj. Drug: Pembrolizumab

Drug: SMT-NK inj.+Pembrolizumab

Pembrolizumab

PLACEBO COMPARATOR

Placebo Comparator: Pembrolizumb Participants will be randomized to receive 200 mg pembrolizumab. Intervention: Drug: Pembrolizumab

Drug: Pembrolizumab

Interventions

SMT-NK inj.+Pembrolizumab DRUG

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.

Pembrolizumab+SMT-NK inj.

Pembrolizumab DRUG

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

Pembrolizumab

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who received a histopathological or cytologic diagnosis of nonresectable, advanced biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer) and patients with refractory disease after chemotherapy and/or patients who have difficulty with chemotherapy due to side effects of chemotherapy.
• Patients who receives an explanation from the trial manager about the purpose, contents, and characteristics of the Investigational products for the clinical trial and is signed by the person, guardian or legal representative in the written informed consent.
• to 80 years old on day of signing informed consent.
• Histopathological or cytologic diagnosis of advanced adenocarcinoma of the biliary tract and those with measurable lesions for RECIST evaluation
• Tumor lesion: Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of 10mm by CT scan
• Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node must be ≥15mm in short axis when assessed by CT scan
• Have a performance status of ≤2 on the ECOG Performance Scale.
• Patients who survival period is expected to be at least 3 months.
• Demonstrate laboratory test results the following conditions:
• ANC (Absolute Neutrophil Count) ≥ 1,500/μL
• Hemoglobin≥ 9 g/dL
• Platelet\> 80,000/μL
• serum BUN \& Creatinine ≤ 2.0 x upper limit of normal (ULN)
• AST \& ALT ≤ 5.0 x upper limit of normal (ULN)
• Bilirubin ≤ 5mg/dL

You may not qualify if:

• Patients who have previous history
• Immune deficiency or autoimmune disease that can be aggravated by immunotherapy (for example: Rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, Crohn's disease, ulcerative colitis, adolescent-developed insulin-dependent diabetes mellitus).
• Immune deficiency disease
• Pneumonia, colitis, hepatitis, nephritis, endocrine diseases associated with immunodeficiency (hypophysis, thyroid dysfunction, Type 1 diabetes, etc.)
• Obvious myocardial failure or uncontrolled arterial hypertension
• Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Non-infectious pneumonia, interstitial lung disease
• Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• Hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) \[qualitative\] is detected) infection or active tuberculosis
• Active infection (if systemic treatment is required)
• Has a diagnosed and/or treated additional malignancy within 5 years prior to signing informed consent except for curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin
• Has a previous history of anti-angiogenic agent treatment before signing informed consent
• Has a known serious allergic history
• Has a known serious mental illness
• Identified the following in Screening:

Sponsors & Collaborators

• SMT bio Co., Ltd.: lead

Study Sites (3)

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, 06273, South Korea

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• SEUNGWOO PARK

  Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JUNGMIN IM

CONTACT

82-02-6297-0515; jungminim@smtbio.co.kr

HAEJIN IM

CONTACT

82-02-6297-0515; imjin@smtbio.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: June 9, 2022
• Primary Completion: January 8, 2025
• Study Completion (Estimated): June 8, 2026
• Last Updated: September 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)