NCT06149481

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)

Recruiting now Phase 1, PHASE2 Last updated 6 April 2026

What this trial tests

Phase 1, PHASE2 trial testing Retifanlimab in Metastatic Colorectal Cancer in 60 participants. Currently enrolling.

Timeline

26 March 2024

Primary endpoint
31 October 2027

31 October 2030

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	26 March 2024
Primary completion	31 October 2027
Estimated completion	31 October 2030
Sites	1 location across United States

Drugs / interventions tested

• Retifanlimab (RETIFANLIMAB) — full drug profile →
• Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform — full drug profile →
• N-803 — full drug profile →
• SX-682 — full drug profile →

Conditions studied

• Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 120, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting cytokine and chemokine signaling pathways for cancer therapy.
   Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
2. Neutrophils at the Crossroads: Unraveling the Multifaceted Role in the Tumor Microenvironment.
   Awasthi D, Sarode A. · · 2024 · cited 41× · PMID 38474175 · DOI 10.3390/ijms25052929
3. Therapeutic potential of tumor-associated neutrophils: dual role and phenotypic plasticity.
   Zhou Y, Shen G, Zhou X, Li J. · · 2025 · cited 39× · PMID 40461514 · DOI 10.1038/s41392-025-02242-7
4. Complex role of neutrophils in the tumor microenvironment: an avenue for novel immunotherapies.
   Zhang M, Qin H, Wu Y, Gao Q. · · 2024 · cited 23× · PMID 39297568 · DOI 10.20892/j.issn.2095-3941.2024.0192
5. Immune Cell Migration to Cancer.
   Ryan AT, Kim M, Lim K. · · 2024 · cited 16× · PMID 38786066 · DOI 10.3390/cells13100844
6. IFNγ-Induced Bcl3, PD-L1 and IL-8 Signaling in Ovarian Cancer: Mechanisms and Clinical Significance.
   Reddy SU, Sadia FZ, Vancura A, Vancurova I. · · 2024 · cited 8× · PMID 39123403 · DOI 10.3390/cancers16152676
7. Colorectal Cancer: Genetic Underpinning and Molecular Therapeutics for Precision Medicine.
   Dosunmu GT, Shergill A. · · 2024 · cited 8× · PMID 38790167 · DOI 10.3390/genes15050538
8. Emerging Immunotherapy Targets in Early Drug Development.
   Morchón-Araujo D, Catani G, Mirallas O, Pretelli G, et al · · 2025 · cited 6× · PMID 40508202 · DOI 10.3390/ijms26115394