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ZN-c3 in Adult Participants With Metastatic Colorectal Cancer

TerminatedPhase 1

Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Conditions: Metastatic Colorectal Cancer

Interventions: ZN-c3, Encorafenib, Cetuximab

Countries: United States, Australia, Germany, Hungary, Italy, Poland, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (27)

Los Angeles, California, United States
Merriam, Kansas, United States
Houston, Texas, United States
Woodville South, South Australia, Australia
Melbourne, Victoria, Australia
Augsburg, Bavaria, Germany
Munich, Bavaria, Germany
Munich, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Berlin, State of Berlin, Germany
Budapest, Budapest, Hungary
Gyöngyös, Hungary
Naples, Campania, Italy
San Giovanni Rotondo, Foggia, Italy
Milan, Milano, Italy
Milan, Milano, Italy
Verona, Veneto, Italy
Krakow, Lesser Poland Voivodeship, Poland
Krakow, Lesser Poland Voivodeship, Poland
Warsaw, Masovian Voivodeship, Poland
Opole, Opole Voivodeship, Poland
Barcelona, Barcelona, Spain
Barcelona, Catalonia, Spain
Córdoba, Cordoba, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Valencia, Valenciana, Comunitat, Spain