ZN-c3 in Adult Participants With Metastatic Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2026-09-25
• Target enrollment: 0
• Participant gender: All

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: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
• Collaborator: Pfizer
• Treatments: Cetuximab

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