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NCT06149481 · ClinicalTrials.gov registry record · Phase 1

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)

A Phase 1 study of Metastatic Colorectal Cancer, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT06149481: Recruiting Phase 1 study of Metastatic Colorectal Cancer, sponsored by National Cancer Institute (NCI).

NCT06149481 is a Phase 1 study of Metastatic Colorectal Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 185-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06149481, a Phase 1 study of Metastatic Colorectal Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Number of DLTs within DLT period (C1 days 1-28). Any toxicities identified.

Conditions Studied

Metastatic Colorectal Cancer

Interventions

  • DRUG Retifanlimab
  • BIOLOGICAL Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform
  • DRUG N-803
  • DRUG SX-682

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-03-26
Est. Completion 2030-10-31
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT06149481 shows while recruiting

NCT06149481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 185-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (68% lower).

The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Retifanlimab is the first listed.

NCT06149481 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT06149481 about?

NCT06149481 is a clinical study titled "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)". 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 ...

What is the current status of trial NCT06149481?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-03-26. Estimated completion is 2030-10-31.

What conditions does trial NCT06149481 study?

This clinical trial studies the following conditions: Metastatic Colorectal Cancer.

What interventions are being tested in trial NCT06149481?

The interventions under investigation include: Retifanlimab (DRUG), Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform (BIOLOGICAL), N-803 (DRUG), SX-682 (DRUG).

Who is sponsoring clinical trial NCT06149481?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06149481 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Colorectal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06149481's enrollment target sits among peer trials

60 28th of 45 higher than 18 of 45 other Metastatic Colorectal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06149481

Source: ClinicalTrials.gov NCT06149481, the US trial registry maintained by the National Library of Medicine. NCT06149481 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.