Trial Title:
ZN-c3 in Adult Participants With Metastatic Colorectal Cancer
NCT ID:
NCT05743036
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Cetuximab
Conditions: Keywords:
Metastatic Colorectal Cancer
CRC
BRAF V600E
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ZN-c3
Description:
ZN-c3 tablet by mouth, in combination with encorafenib
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Intervention type:
Drug
Intervention name:
Encorafenib
Description:
Encorafenib capsule by mouth, in combination with ZN-c3
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Other name:
BRAFTOVI®
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Infusion
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Other name:
ERBITUX®
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.
Criteria for eligibility:
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:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
Alliance for Multispecialty Research, LLC
Address:
City:
Merriam
Zip:
66204
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
The Queen Elizabeth Hospital
Address:
City:
Woodville South
Zip:
5011
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Hämatologie- Onkologie im Zentrum MVZ GmbH
Address:
City:
Augsburg
Zip:
86150
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum der Universität München Großhadern
Address:
City:
Muenchen
Zip:
81377
Country:
Germany
Status:
Recruiting
Facility:
Name:
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
Address:
City:
Muenchen
Zip:
81737
Country:
Germany
Status:
Recruiting
Facility:
Name:
Institut für Klinisch Onkologische Forschung
Address:
City:
Frankfurt
Zip:
60488
Country:
Germany
Status:
Recruiting
Facility:
Name:
DRK Kliniken Berlin - Köpenick
Address:
City:
Berlin
Zip:
12559
Country:
Germany
Status:
Recruiting
Facility:
Name:
Semmelweis University-Department of Internal Medicine and Oncology
Address:
City:
Budapest
Zip:
1083
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Clinexpert Kft. Bugat Pal Korhaz
Address:
City:
Gyöngyös
Zip:
3200
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Casa Sollievo della Sofferenza
Address:
City:
San Giovanni Rotondo
Zip:
71013
Country:
Italy
Status:
Recruiting
Facility:
Name:
AOUI Verona
Address:
City:
Verona
Zip:
37126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Recruiting
Facility:
Name:
Szpital Uniwersytecki w Krakowie
Address:
City:
Kraków
Zip:
31-501
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Address:
City:
Kraków
Zip:
31-826
Country:
Poland
Status:
Recruiting
Facility:
Name:
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Address:
City:
Warsaw
Zip:
02-034
Country:
Poland
Status:
Recruiting
Facility:
Name:
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
Address:
City:
Opole
Zip:
45-061
Country:
Poland
Status:
Recruiting
Facility:
Name:
Parc de Salut Mar - Hospital del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Reina Sofia
Address:
City:
Córdoba
Zip:
14004
Country:
Spain
Status:
Recruiting
Facility:
Name:
Fundación Instituto Valenciano de Oncología
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Puerta de Hierro Majadahonda
Address:
City:
Madrid
Zip:
28222
Country:
Spain
Status:
Recruiting
Start date:
February 27, 2023
Completion date:
September 25, 2026
Lead sponsor:
Agency:
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Agency class:
Industry
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Source:
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05743036
