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
Description
Brief 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.
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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