Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
Summary
This study has two phases: Dose Escalation and Dose Expansion.
In Phase One (Dose Escalation), participants will receive different doses of the study drug (ZN-c3) in combination with different doses of encorafenib and a fixed dose of cetuximab.
In Phase Two (Dose Expansion), participants will receive the recommended dose of ZN-c3 and encorafenib as determined in the Dose Escalation phase, which will be given in combination with cetuximab.
ZN-c3 and encorafenib will be given as an oral capsule, and cetuximab will be given as an infusion.
Conditions
This trial is treating people with metastatic Stage IV colorectal adenocarcinoma
Eligibility
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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Scientific Title
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
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