Program Status
Active, not recruitingPhase
Phase 1Prior Immunotherapy Allowed
YesCRC-directed Trial
YesDrugs
cetuximab, encorafenib, ZN-c3Tags
MSI-H/ MMRd, MSS/ MMRpComments
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.
Helpful Links
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8891215/ https://www.cabrini.com.au/app/uploads/55.-Gary-Richardson-Wee1-inhibitor.pdf| Location | Location Status |
|---|---|
| United States | |
|
USC Norris Comprehensive Cancer Center Los Angeles, California 90033 |
Active, not recruiting |
|
Alliance for Multispecialty Research, LLC Merriam, Kansas 66204 |
Active, not recruiting |
|
University of Texas MD Anderson Cancer Center Houston, Texas 77030 |
Active, not recruiting |
| Australia | |
|
The Queen Elizabeth Hospital Woodville South, South Australia 5011 |
Active, not recruiting |
|
Peter MacCallum Cancer Centre Melbourne, Victoria 3000 |
Active, not recruiting |
| Germany | |
|
Hämatologie- Onkologie im Zentrum MVZ GmbH Augsburg, Bayern 86150 |
Active, not recruiting |
|
Klinikum der Universität München Großhadern Muenchen, Bayern 81377 |
Active, not recruiting |
|
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie Muenchen, Bayern 81737 |
Active, not recruiting |
|
Institut für Klinisch Onkologische Forschung Frankfurt, Hessen 60488 |
Active, not recruiting |
|
DRK Kliniken Berlin - Köpenick Berlin 12559 |
Active, not recruiting |
| Hungary | |
|
Semmelweis University-Department of Internal Medicine and Oncology Budapest 1083 |
Active, not recruiting |
|
Clinexpert Kft. Bugat Pal Korhaz Gyöngyös 3200 |
Active, not recruiting |
| Italy | |
|
Istituto Nazionale Tumori IRCCS Fondazione Pascale Napoli, Campania 80131 |
Active, not recruiting |
|
IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo, Foggia 71013 |
Active, not recruiting |
|
AOUI Verona Verona, Veneto 37126 |
Active, not recruiting |
|
Istituto Europeo di Oncologia Milano 20141 |
Active, not recruiting |
|
ASST Grande Ospedale Metropolitano Niguarda Milano 20162 |
Active, not recruiting |
| Poland | |
|
Szpital Uniwersytecki w Krakowie Kraków, Malopolskie 31-501 |
Active, not recruiting |
|
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Kraków, Malopolskie 31-826 |
Active, not recruiting |
|
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie Warsaw, Mazowieckie 02-034 |
Active, not recruiting |
|
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego Opole, Opolskie 45-061 |
Active, not recruiting |
| Spain | |
|
Parc de Salut Mar - Hospital del Mar Barcelona, Cataluna 08003 |
Active, not recruiting |
|
Hospital Universitario Reina Sofia Córdoba, Cordoba 14004 |
Active, not recruiting |
|
Fundación Instituto Valenciano de Oncología Valencia, Valenciana, Comunitat 46009 |
Active, not recruiting |
|
Hospital Universitari Vall d'Hebron Barcelona 08035 |
Active, not recruiting |
|
Hospital Universitario La Paz Madrid 28046 |
Active, not recruiting |
|
Hospital Universitario Puerta de Hierro Majadahonda Madrid 28222 |
Active, not recruiting |
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
