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NCT06102902 · ClinicalTrials.gov registry record · Phase 1

Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer

A Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
15
Study locations

NCT06102902 is a Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (72% lower). The trial reports 15 study locations across 8 states.

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The verdict

NCT06102902, a Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
15
Study locations

Study Summary

This phase I trial tests the safety, best dose, and effectiveness of ZEN003694 in combination with cetuximab and encorafenib in treating patients with colorectal cancer that has not responded to previous treatment (refractory), that has come back after a period of improvement (relapsed), and that has spread from where it first started (primary site) to other places in the body (metastatic). ZEN003694 is a protein inhibitor that binds to BET proteins. When ZEN003694 binds to BET proteins, it disrupts gene expression. Preventing the expression of certain growth-promoting genes may inhibit proliferation of tumor cells that over-express BET proteins. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Encorafenib is an enzyme inhibitor. It inhibits pathways that are responsible for controlling cell proliferation and survival, which may lead to a decrease in tumor cell proliferation. Both cetuximab and encorafenib have been approved to treat cancer. Adding ZEN003694 to cetuximab and encorafenib may be more effective at treating patients with refractory metastatic colorectal cancer than giving the usual treatment (cetuximab and encorafenib) alone.

Conditions Studied

Stage IV Colorectal Cancer AJCC v8 Metastatic Colorectal Adenocarcinoma Refractory Colorectal Adenocarcinoma Recurrent Colorectal Adenocarcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • BIOLOGICAL Cetuximab
  • PROCEDURE Biopsy Procedure
  • DRUG BET Bromodomain Inhibitor ZEN-3694

Study Locations (15)

California

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange

Kansas

  • University of Kansas Clinical Research Center - Fairway
  • University of Kansas Cancer Center - Kansas City
  • University of Kansas Hospital-Indian Creek Campus - Overland Park
  • University of Kansas Hospital-Westwood Cancer Center - Westwood

Virginia

  • University of Virginia Cancer Center - Charlottesville
  • VCU Massey Comprehensive Cancer Center - Richmond

Colorado

  • UCHealth University of Colorado Hospital - Aurora

Louisiana

  • Ochsner Medical Center Jefferson - New Orleans

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-06-05
Est. Completion 2027-01-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06102902

The ClinicalTrials.gov registry entry for NCT06102902 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (72% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Stage IV Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06102902 reports 15 study locations spanning 8 distinct geographic areas - top geographies include California, Kansas, Virginia.

Frequently Asked Questions

What is clinical trial NCT06102902 about?

NCT06102902 is a clinical study titled "Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer". This phase I trial tests the safety, best dose, and effectiveness of ZEN003694 in combination with cetuximab and encorafenib in treating patients with colorectal cancer that has not responded to previous treatment (refractory), that has come back after a period of improvement (relapsed), and that ha...

What is the current status of trial NCT06102902?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-06-05. Estimated completion is 2027-01-30.

What conditions does trial NCT06102902 study?

This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v8, Metastatic Colorectal Adenocarcinoma, Refractory Colorectal Adenocarcinoma, Recurrent Colorectal Adenocarcinoma.

What interventions are being tested in trial NCT06102902?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cetuximab (BIOLOGICAL), Biopsy Procedure (PROCEDURE), BET Bromodomain Inhibitor ZEN-3694 (DRUG).

Who is sponsoring clinical trial NCT06102902?

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

Where is trial NCT06102902 being conducted?

This trial has 15 study locations across California, Colorado, Kansas, Louisiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.