Clinical trial · Interventional
The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment
An Open, Multicenter Phase II Clinical Study to Evaluate Safety and Efficacy of HLX208 (BRAF V600E Inhibitor) Combined With Cetuximab in Patients With Metastatic Colorectal Cancer (mCRC)
NCT04984369CI-TRIAL-00068943unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment
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 |
|---|---|---|---|
| CRC | Colorectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab Injection [Erbitux] | Drug | Cetuximab | ALIAS |
| HLX208 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Never use other BRAF inhibitor therapy
- description
- Never use other BRAF inhibitor therapy
- interventionNames
- Drug: HLX208
- Drug: Cetuximab Injection [Erbitux]
- type
- EXPERIMENTAL
- label
- PD after other BRAF inhibitor therapy N=5~40
- description
- PD after other BRAF inhibitor therapy
- interventionNames
- Drug: HLX208
- Drug: Cetuximab Injection [Erbitux]
- type
- EXPERIMENTAL
- label
- SD but intolerant after other BRAF inhibitor therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age\>=18Y * Good Organ Function * Expected survival time ≥ 3 months * Metastatic/recurrent advanced BRAF+ mCRC that have been diagnosed histologically and have failed first line treatment * ECOG score 0-1; Exclusion Criteria: * arm 1 : Previous treatment with BRAF inhibitors or MEK inhibitors * Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable). * Active clinical severe infection; * A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
References
Publications (0)
Data not yet available
No reference posted for this study.