Clinical trial · Interventional
ZN-c3 in Adult Participants With Metastatic Colorectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to change in therapeutic landscape.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Encorafenib | Drug | Encorafenib | ALIAS |
| ZN-c3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Participants will receive different doses of ZN-c3 in combination with different doses of Encorafenib and a fixed dose of Cetuximab
- interventionNames
- Drug: ZN-c3
- Drug: Encorafenib
- Drug: Cetuximab
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- Participants will receive recommended dose of ZN-c3 and encorafenib as determined in dose escalation phase in combination with cetuximab
- interventionNames
- Drug: ZN-c3
- Drug: Encorafenib
- Drug: Cetuximab
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available