ZN-c3 in Adult Participants With BRAF mutant Metastatic Colorectal Cancer

Program Status

Terminated

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

cetuximab, encorafenib, ZN-c3

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Only for patients with metastatic BRAF V600E mutant colorectal cancer. Must have been previously treated with one or two treatment regimens.

ZN-c3: azenosertib; experimental Wee1 inhibitor. Oral.

Encorafenib: small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway (Braftovi®). Oral.

Cetuximab: (Erbitux®) epidermal growth factor receptor (EGFR) inhibitor. Intravenous.

Location Location Status
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
Terminated
Alliance for Multispecialty Research, LLC
Merriam, Kansas 66204
Terminated
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Terminated
Australia
The Queen Elizabeth Hospital
Woodville South, South Australia 5011
Terminated
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Terminated
Germany
Hämatologie- Onkologie im Zentrum MVZ GmbH
Augsburg, Bayern 86150
Terminated
Klinikum der Universität München Großhadern
Muenchen, Bayern 81377
Terminated
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
Muenchen, Bayern 81737
Terminated
Institut für Klinisch Onkologische Forschung
Frankfurt, Hessen 60488
Terminated
DRK Kliniken Berlin - Köpenick
Berlin 12559
Terminated
Hungary
Semmelweis University-Department of Internal Medicine and Oncology
Budapest 1083
Terminated
Clinexpert Kft. Bugat Pal Korhaz
Gyöngyös 3200
Terminated
Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, Campania 80131
Terminated
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia 71013
Terminated
AOUI Verona
Verona, Veneto 37126
Terminated
Istituto Europeo di Oncologia
Milano 20141
Terminated
ASST Grande Ospedale Metropolitano Niguarda
Milano 20162
Terminated
Poland
Szpital Uniwersytecki w Krakowie
Kraków, Malopolskie 31-501
Terminated
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Kraków, Malopolskie 31-826
Terminated
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Mazowieckie 02-034
Terminated
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
Opole, Opolskie 45-061
Terminated
Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, Cataluna 08003
Terminated
Hospital Universitario Reina Sofia
Córdoba, Cordoba 14004
Terminated
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat 46009
Terminated
Hospital Universitari Vall d'Hebron
Barcelona 08035
Terminated
Hospital Universitario La Paz
Madrid 28046
Terminated
Hospital Universitario Puerta de Hierro Majadahonda
Madrid 28222
Terminated

Inclusion Criteria

Inclusion Criteria:

* 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

Exclusion Criteria

Exclusion Criteria:

* 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

NCT ID

NCT05743036

Date Trial Added

2023-02-24

Updated Date

2025-08-08