ZN-c3 in Adult Participants With Metastatic Colorectal Cancer

Last updated: January 30, 2025
Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Overall Status: Active - Not Recruiting

Phase

1

Condition

Colorectal Cancer

Metastatic Cancer

Treatment

Encorafenib

ZN-c3

Cetuximab

Clinical Study ID

NCT05743036
ZN-c3-016
Z0011001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability, and potential clinical benefits of ZN-c3 administered in combination with encorafenib and cetuximab in adult participants with metastatic BRAF V600E mutant colorectal cancer previously treated with one or two treatment regimens.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic Stage IV colorectaladenocarcinoma.

  • Documented evidence of a BRAF V600E mutation in tumor tissue or blood

  • Presence of measurable disease per RECIST version 1.1 guidelines.

  • Disease progression after 1 or 2 previous systemic regimens for metastatic disease

  • Adequate bone marrow function

  • Adequate hepatic and renal function

Exclusion

Exclusion Criteria:

  • Documented clinical disease progression or radiographic disease progression duringthe screening period

  • Leptomeningeal disease.

  • Symptomatic brain metastasis.

  • Presence of acute or chronic pancreatitis.

  • Unable to swallow, retain, and absorb oral medications.

  • Clinically significant cardiovascular diseases

  • Evidence of active noninfectious pneumonitis.

  • Evidence of active and uncontrolled bacterial or viral infection, within 2 weeksprior to start of any of the study interventions

  • Participants with known positivity for HIV

  • Active hepatitis B or hepatitis C infection

  • Concurrent or previous other malignancy within 2 years of study entry

  • Has had an allogeneic tissue/solid organ transplant

  • Pregnant or females of childbearing potential who have a positive β-hCG laboratorytest result within 14 days prior to enrollment or is breastfeeding

Study Design

Total Participants: 44
Treatment Group(s): 3
Primary Treatment: Encorafenib
Phase: 1
Study Start date:
February 27, 2023
Estimated Completion Date:
September 25, 2026

Connect with a study center

  • The Queen Elizabeth Hospital

    Woodville South, South Australia 5011
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Hämatologie- Onkologie im Zentrum MVZ GmbH

    Augsburg, Bayern 86150
    Germany

    Site Not Available

  • Klinikum der Universität München Großhadern

    Muenchen, Bayern 81377
    Germany

    Site Not Available

  • Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie

    Muenchen, Bayern 81737
    Germany

    Site Not Available

  • Institut für Klinisch Onkologische Forschung

    Frankfurt, Hessen 60488
    Germany

    Site Not Available

  • DRK Kliniken Berlin - Köpenick

    Berlin, 12559
    Germany

    Site Not Available

  • Semmelweis University-Department of Internal Medicine and Oncology

    Budapest, 1083
    Hungary

    Site Not Available

  • Clinexpert Kft. Bugat Pal Korhaz

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Napoli, Campania 80131
    Italy

    Site Not Available

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia 71013
    Italy

    Site Not Available

  • AOUI Verona

    Verona, Veneto 37126
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia

    Milano, 20141
    Italy

    Site Not Available

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

    Kraków, Malopolskie 31-826
    Poland

    Site Not Available

  • Szpital Uniwersytecki w Krakowie

    Kraków, Malopolskie 31-501
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

    Warsaw, Mazowieckie 02-034
    Poland

    Site Not Available

  • Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

    Opole, Opolskie 45-061
    Poland

    Site Not Available

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, Cataluna 08003
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba 14004
    Spain

    Site Not Available

  • Fundación Instituto Valenciano de Oncología

    Valencia, Valenciana, Comunitat 46009
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222
    Spain

    Site Not Available

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Merriam, Kansas 66204
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.