ZN-c3 in Adult Participants With Metastatic Colorectal Cancer

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 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