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 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 prolif

Trial Details

NCT ID

NCT06102902

Phase

PHASE1

Sponsor

National Cancer Institute (NCI)

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

BET Bromodomain Inhibitor ZEN-3694
Biopsy Procedure
Biospecimen Collection
Cetuximab
Computed Tomography
Echocardiography Test

Locations (sample)

Irvine, California, United States|33.66946,-117.82311
Los Angeles, California, United States|34.05223,-118.24368
Los Angeles, California, United States|34.05223,-118.24368
Orange, California, United States|33.78779,-117.85311
Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

Patients must have histologically confirmed and radiographically measurable metastatic colorectal adenocarcinoma with known BRAF V600E mutation, co…
Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ZEN003694 in combination with cetuximab and encorafen…
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Absolute neutrophil count ≥ 1,500/mcL

For full eligibility, visit ClinicalTrials.gov.

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