ZN-c3 in Adult Participants With Metastatic Colorectal Cancer
Megadott ok: Study terminated due to change in therapeutic landscape.
Key facts
- Where
- Budapest és Gyöngyös, MagyarországSee the 2 sites
- Phase
- 1. fázis
Where in Magyarország
- Semmelweis University-Department of Internal Medicine and OncologyBudapest, MagyarországNo longer taking part
- Clinexpert Kft Bugat Pal KorhazGyöngyös, MagyarországNo longer taking part
Trial details
- Who runs it
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
- Trial code
- NCT05743036
- Record updated
- 2025. augusztus 8.
- Original description
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.Read full original descriptionShow less
A Phase 1/2, Open-Label, Multi-Center Study of ZN-c3 Administered in Combination With Encorafenib and Cetuximab in Adults With Metastatic Colorectal Cancer
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.
Inclusion: 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: Unable to swallow, retain, and absorb oral medications; Evidence of active and uncontrolled bacterial or viral infection, within 2 weeks prior to start of any of the study interventions; Has had an allogeneic tissue/solid organ transplant; Documented clinical disease progression or radiographic disease progression during the screening period; Leptomeningeal disease; Clinically significant cardiovascular diseases; Evidence of active noninfectious pneumonitis; Participants with known positivity for HIV; Active hepatitis B or hepatitis C infection; Concurrent or previous other malignancy within 2 years of study entry; Pregnant or females of childbearing potential who have a positive β-hCG laboratory test result within 14 days prior to enrollment or is breastfeeding; Symptomatic brain metastasis; Presence of acute or chronic pancreatitis.