The trial is taking place at:
H

Hospital Universitario Puerta de Hierro Majadahonda | Departamento de Oncologia Medica

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ZN-c3 in Adult Participants With Metastatic Colorectal Cancer

K

K-Group Beta

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: ZN-c3
Drug: Cetuximab
Drug: Encorafenib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05743036
Z0011001 (Other Identifier)
ZN-c3-016

Details and patient eligibility

About

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.

Enrollment

82 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

82 participants in 2 patient groups

Dose Escalation
Experimental group
Description:
Participants will receive different doses of ZN-c3 in combination with different doses of Encorafenib and a fixed dose of Cetuximab
Treatment:
Drug: Encorafenib
Drug: Cetuximab
Drug: ZN-c3
Dose Expansion
Experimental group
Description:
Participants will receive recommended dose of ZN-c3 and encorafenib as determined in dose escalation phase in combination with cetuximab
Treatment:
Drug: Encorafenib
Drug: Cetuximab
Drug: ZN-c3

Trial contacts and locations

27

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Central trial contact

K-Group Beta, Inc. a subsidiary of Zentalis Pharmaceuticals

Data sourced from clinicaltrials.gov

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