The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment
NCT04984369 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-08-21
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
Conditions
Interventions
- DRUG
-
HLX208
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
- DRUG
-
Cetuximab Injection [Erbitux]
Cetuximab 500 mg/m2 IV Q2W
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-11
- Primary Completion
- 2024-06-15
- Completion
- 2025-01-15
Countries
- China
Study Locations
More Related Trials
-
Continuing Cetuximab Plus Chemotherapy After First Progression in Wild-type KRAS, NRAS and BRAF V600E Metastatic Colorectal Cancer
NCT04718038 ·Status: COMPLETED
-
Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma
NCT00044863 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Study to Evaluate Efficacy and Safety of Serplulimab(HLX10) Combined With Bevacizumab(HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)
NCT04547166 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With XELOX for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer.
NCT00531115 ·Status: TERMINATED ·Phase: PHASE2
-
Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
NCT01719380 ·Status: COMPLETED ·Phase: PHASE2
-
Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer
NCT06763029 ·Status: RECRUITING ·Phase: PHASE2
-
Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer
NCT01564810 ·Status: UNKNOWN ·Phase: PHASE4
-
A Phase I/II Study of XELOXIRI and Bevacizumab as First-line Treatment in Metastatic Colorectal Cancer
NCT04380103 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Combination Chemotherapy and Cetuximab as First-Line Therapy in Treating Patients With Advanced and/or Metastatic Colorectal Cancer
NCT00640081 ·Status: COMPLETED ·Phase: PHASE2
-
Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
NCT00079066 ·Status: COMPLETED ·Phase: PHASE3
-
Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer
NCT04853043 ·Status: TERMINATED ·Phase: PHASE2
-
Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients with MCRC
NCT05584137 ·Status: TERMINATED ·Phase: PHASE2
-
A Clinical Study to Compare the Efficacy, Safety and Immunogenicity of HLX04 and Bevacizumab Combined XELOX or mFOLFOX6 in the First-line Treatment of mCRC
NCT03511963 ·Status: COMPLETED ·Phase: PHASE3
-
Cetuximab in Combination With Dabrafenib and Tislelizumab in BRAF Mutated Treatment of Advanced Colorectal Cancer
NCT05963087 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Cetuximab in Treating Patients With Stage IV Colorectal Cancer
NCT00020930 ·Status: COMPLETED ·Phase: PHASE2
-
Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study
NCT02316496 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer
NCT00478634 ·Status: COMPLETED ·Phase: PHASE1
-
Cetuximab & Celecoxib for Metastatic Colorectal Cancer or Colorectal Cancer That Cannot Be Removed by Surgery
NCT00466505 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
NCT03356158 ·Status: UNKNOWN ·Phase: PHASE1
-
Tolerability and Safety of Vemurafenib, Cetuximab Combined With Camrelizumab for BRAF V600E-mutated /MSS Metastatic Colorectal Cancer
NCT05019534 ·Status: UNKNOWN ·Phase: PHASE1
-
Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy
NCT00336856 ·Status: COMPLETED ·Phase: PHASE2
-
Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type mCRC
NCT06379399 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
XELOX+Bevacizumab and XELIRI + Bevacizumab Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer
NCT03511183 ·Status: UNKNOWN ·Phase: PHASE2
-
Erbitux (Cetuximab) Given Alone to Patients With EGFR-Negative Metastatic Colon or Rectal Cancer That is Refractory to Chemotherapy
NCT00083720 ·Status: COMPLETED ·Phase: PHASE2
-
QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
NCT05799820 ·Status: UNKNOWN ·Phase: PHASE2