Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC) - Trial NCT06149481
Access comprehensive clinical trial information for NCT06149481 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by National Cancer Institute (NCI) and is currently Not yet recruiting. The study focuses on Metastatic Colorectal Cancer. Target enrollment is 50 participants.
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Study Focus
Sponsor & Location
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
Timeline & Enrollment
Phase 1/2
Dec 10, 2023
Oct 31, 2028
Primary Outcome
Phase I: Safety profiles of the IO regimens consisting of retifanlimab, TriAdeno vaccine, N-803 (A1), and retifanlimab, TriAdeno vaccine, N-803, SX-682 (A2) in participants with metastatic colorectal cancer,Phase II: Overall response rate (ORR) defined as the CR+PR of the IO regimen in mCRC
Summary
Background:
 
 Each year, more than 32,000 people in the United States are diagnosed with colorectal cancer
 that has returned or progressed after treatment and spread to other organs. This is called
 metastatic colorectal cancer (mCRC). Most people with mCRC survive only about 2 years.
 
 Objective:
 
 To test the ability of a combination of up to 4 experimental anti-cancer drugs treat mCRC.
 The names of these drugs are retifanlimab, TriAdeno vaccine, N-803, and SX-682. They are
 described below.
 
 Eligibility:
 
 Adults aged 18 years or older with mCRC. Participants must have
 
 Design:
 
 Participants will be screened. This includes having a physical exam, blood tests, urine
 tests, and imaging tests. If signed on to the study, participants will have 2 tumor biopsies.
 One when starting the study and once about 8 weeks after bring on the study. Participants
 will receive $500 for each biopsy.
 
 Participants will be treated with either 3 or 4 drugs and will receive a detailed calendar
 explaining when each drug is given.
 
 Retifanlimab is given every 4 weeks through an IV (an IV is tube attached to a needle
 inserted into a vein in the arm). N-803 is injected under the skin on the abdomen every 4
 weeks.
 
 TriAdeno vaccine is injected under the skin of the upper arm or thigh once a month for 3
 doses and then once every 3 months.
 
 Some participants will also receive a 4th drug. SX-682 is a pill taken by mouth. Participants
 will take this drug 2 times a day at home for about 3 weeks of each month.
 
 Study treatment will continue up to 2 years. Follow-up phone calls/emails may continue for 3
 more years.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06149481
Non-Device Trial