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SX-682 and Nivolumab for the Treatment of RAS-Mutated, MSS Unresectable or Metastatic Colorectal Cancer, the STOPTRAFFIC-1 Trial

NCT04599140 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-01-22

No results posted yet for this study

Summary

This phase Ib/II trial studies the side effects and best dose of SX-682 that can be given alone and in combination with nivolumab in treating patients with RAS-Mutated, microsatellite stable (MSS) colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). SX-682 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SX-682 alone and together with nivolumab may kill more tumor cells.

Conditions

  • Metastatic Colon Adenocarcinoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Rectal Adenocarcinoma
  • Stage III Colon Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8
  • Stage IIIA Colon Cancer AJCC v8
  • Stage IIIA Rectal Cancer AJCC v8
  • Stage IIIB Colon Cancer AJCC v8
  • Stage IIIB Rectal Cancer AJCC v8
  • Stage IIIC Colon Cancer AJCC v8
  • Stage IIIC Rectal Cancer AJCC v8
  • Stage IV Colon Cancer AJCC v8
  • Stage IV Rectal Cancer AJCC v8
  • Stage IVA Colon Cancer AJCC v8
  • Stage IVA Rectal Cancer AJCC v8
  • Stage IVB Colon Cancer AJCC v8
  • Stage IVB Rectal Cancer AJCC v8
  • Stage IVC Colon Cancer AJCC v8
  • Stage IVC Rectal Cancer AJCC v8
  • Unresectable Colon Adenocarcinoma
  • Unresectable Rectal Adenocarcinoma

Interventions

DRUG

CXCR1/2 Inhibitor SX-682

Given PO

BIOLOGICAL

Nivolumab

Given IV

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Syntrix Biosystems, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Alisha Bent, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04599140 on ClinicalTrials.gov