Clinical trial · Interventional
The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation
An Open Label, Multicenter Phase II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation
NCT05127759CI-TRIAL-00068661unknownPhase 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)
The purpose of this study was to assess efficacy, safety and PK in metastatic colorectal cancer (mCRC) given HLX208 (BRAF V600E inhibitor).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| mCRC | — | UNRESOLVED | — |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLX208 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HLX208
- description
- Participants receive HLX208 450mg bid po
- interventionNames
- Drug: HLX208
Primary outcomes (1)
- measure
- ORR
- timeFrame
- up to 2 years
- description
- Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
Secondary outcomes (2)
- measure
- PFS
- timeFrame
- from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age\>=18Y; 2. Good Organ Function; 3. Expected survival time ≥ 3 months; 4. Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment; 5. At least one measurable lesion as per RECIST v1.1; 6. ECOG score 0-1. Exclusion Criteria: 1. Previous treatment with BRAF inhibitors or MEK inhibitors 2. Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable). 3. Active clinical severe infection; 4. 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.