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RecruitingLast updated: 9 November 2023

This study is evaluating how safe, tolerable and effective administering a new targeted therapy (called ZN-c3) with an existing combination of targeted therapies (encorafenib and cetuximab) is in adults with metastatic BRAF V600E mutant colorectal cancer who have previously had treatmentA Phase 1/2, Open-Label, Multi-Center Study of ZN-c3 Administered in Combination With Encorafenib and Cetuximab in Adults With Metastatic Colorectal Cancer

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 patients with metastatic Stage IV colorectal adenocarcinoma

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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