NCT06149481View on ClinicalTrials.gov

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)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 26, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2028

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Retifanlimab

500 mg infused via IV over 30 minutes every 28 days

BIOLOGICAL

Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform

5x10\^11 virus particles per 1 mL administered via subcutaneous injection in the upper arm and anterolateral upper thigh on Day 1 of Cycles 1, 2, 3 and every 3 cycles after that

DRUG

N-803

15 ug/kg administered via subcutaneous injection to the abdomen every 28 days

DRUG

SX-682

100 mg administered orally twice per day on days 6-26 of every cycle

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH