ZN-c3 in Adult Participants With Metastatic Colorectal Cancer

Stopped early · Phase 1

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT05743036

Run by

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

People needed

44

Starts

2023-02-27

Expected to finish

2025-07-09

Last updated by the study team

2025-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed metastatic Stage IV colorectal adenocarcinoma.
• 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

You may not qualify if…

• Documented clinical disease progression or radiographic disease progression during the 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 weeks prior 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 laboratory test result within 14 days prior to enrollment or is breastfeeding

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Alliance for Multispecialty Research, LLC — Merriam, Kansas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• The Queen Elizabeth Hospital — Woodville South, South Australia, Australia
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• Hämatologie- Onkologie im Zentrum MVZ GmbH — Augsburg, Bavaria, Germany
• Klinikum der Universität München Großhadern — Munich, Bavaria, Germany
• Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie — Munich, Bavaria, Germany
• Institut für Klinisch Onkologische Forschung — Frankfurt am Main, Hesse, Germany
• DRK Kliniken Berlin - Köpenick — Berlin, State of Berlin, Germany
• Semmelweis University-Department of Internal Medicine and Oncology — Budapest, Budapest, Hungary
• Clinexpert Kft. Bugat Pal Korhaz — Gyöngyös, Hungary
• Istituto Nazionale Tumori IRCCS Fondazione Pascale — Naples, Campania, Italy
• IRCCS Casa Sollievo della Sofferenza — San Giovanni Rotondo, Foggia, Italy
• Istituto Europeo di Oncologia — Milan, Milano, Italy
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Milano, Italy
• AOUI Verona — Verona, Veneto, Italy
• Szpital Uniwersytecki w Krakowie — Krakow, Lesser Poland Voivodeship, Poland
• Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie — Krakow, Lesser Poland Voivodeship, Poland
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie — Warsaw, Masovian Voivodeship, Poland
• Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego — Opole, Opole Voivodeship, Poland
• Hospital Universitari Vall d'Hebron — Barcelona, Barcelona, Spain
• Parc de Salut Mar - Hospital del Mar — Barcelona, Catalonia, Spain
• Hospital Universitario Reina Sofia — Córdoba, Cordoba, Spain
• Hospital Universitario La Paz — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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