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Not Yet Recruiting
NCT05743036
ZN-c3 in Adult Participants With Metastatic Colorectal Cancer
Conditions: Metastatic Colorectal Cancer
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1, PHASE2
Enrollment: 82
Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
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.
Eligibility Criteria
Inclusion Criteria:Histologically or cytologically confirmed metastatic Stage IV colorectal adenocarcinoma.Documented evidence of a BRAF V600E mutation in tumor tissue or bloodPresence of measurable disease per RECIST version 1.1 guidelines.Disease progression after 1 or 2 previous systemic regimens for metastatic diseaseAdequate bone marrow functionAdequate hepatic and renal functionExclusion Criteria:Documented clinical disease progression or radiographic disease progression during the screening periodLeptomeningeal disease.Symptomatic brain metastasis.Presence of acute or chronic pancreatitis.Unable to swallow, retain, and absorb oral medications.Clinically significant cardiovascular diseasesEvidence of active noninfectious pneumonitis.Evidence of active and uncontrolled bacterial or viral infection, within 2 weeks prior to start of any of the study interventionsParticipants with known positivity for HIVActive hepatitis B or hepatitis C infectionConcurrent or previous other malignancy within 2 years of study entryHas had an allogeneic tissue/solid organ transplantPregnant or females of childbearing potential who have a positive β-hCG laboratory test result within 14 days prior to enrollment or is breastfeeding
Source: ClinicalTrials.gov (NCT05743036). StuddyBuddy aggregates publicly available trial information.