ZN-c3 in Adult Participants With Metastatic Colorectal Cancer
NCT ID: NCT05743036
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
44 participants
INTERVENTIONAL
2023-02-27
2025-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Participants will receive different doses of ZN-c3 in combination with different doses of Encorafenib and a fixed dose of Cetuximab
ZN-c3
ZN-c3 tablet by mouth, in combination with encorafenib
Encorafenib
Encorafenib capsule by mouth, in combination with ZN-c3
Cetuximab
Infusion
Dose Expansion
Participants will receive recommended dose of ZN-c3 and encorafenib as determined in dose escalation phase in combination with cetuximab
ZN-c3
ZN-c3 tablet by mouth, in combination with encorafenib
Encorafenib
Encorafenib capsule by mouth, in combination with ZN-c3
Cetuximab
Infusion
Interventions
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ZN-c3
ZN-c3 tablet by mouth, in combination with encorafenib
Encorafenib
Encorafenib capsule by mouth, in combination with ZN-c3
Cetuximab
Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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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
Napoli, 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
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Madrid, Spain
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat, Spain
Countries
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Other Identifiers
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Z0011001
Identifier Type: OTHER
Identifier Source: secondary_id
ZN-c3-016
Identifier Type: -
Identifier Source: org_study_id
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