CRC
Conditions
Brief summary
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
Interventions
DRUGHLX208
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
Cetuximab 500 mg/m2 IV Q2W
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 2 years | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years] | Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 ) |
| OS | from the date of first dose until the date of death from any cause，assessed up to 2 years | Overall survival |
Countries
China
Outcome results
None listed