Cetuximab is an EGFR-targeted chimeric monoclonal antibody oncology therapy marketed as Erbitux. It is used in metastatic colorectal cancer and head and neck cancers, with biomarker selection in colorectal use. It is administered via intravenous infusion and is prescription-only.
Phase 3 BREAKWATER found encorafenib plus cetuximab plus FOLFIRI improved PFS and response in first-line BRAF V600E-mutant metastatic colorectal cancer. OS data remain immature.
DelveInsight pipeline reports reveal robust clinical development across three cancer indications, with 45+ companies advancing cutaneous squamous cell carcinoma therapies, 70+ companies developing liver cancer treatments, and multiple hepatocellular carcinoma candidates receiving FDA designations in 2025-2026.
AstraZeneca terminated its Phase I/IIa trial of AZD0022 for KRASG12D-mutant cancers, withdrew a planned saruparib ovarian cancer platform study, and completed a real-world non-small cell lung cancer treatment review.
Pfizer reported positive Phase 3 trial results for BRAFTOVI combination therapy in metastatic colorectal cancer and received FDA Priority Review for HYMPAVZI expansion to hemophilia patients including children.
Phase 3 BREAKWATER trial shows encorafenib plus cetuximab and chemotherapy achieved 30.3 months median overall survival versus 15.1 months with standard therapy in previously untreated BRAF V600E-mutant metastatic colorectal cancer.
Pfizer announced positive progression-free survival results from the BREAKWATER trial evaluating Braftovi in combination with cetuximab and Folfiri in previously untreated metastatic colorectal cancer patients with BRAF V600E mutation.
Pfizer announced positive results from Cohort 3 of the Phase 3 BREAKWATER trial, showing BRAFTOVI combined with cetuximab and FOLFIRI significantly improved progression-free survival in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07549399 |
SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC |
NOT_YET_RECRUITING | PHASE3 |
| NCT07543471 |
A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | PHASE1 |
| NCT07535112 |
A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation |
RECRUITING | PHASE1 |
| NCT07506109 |
A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer |
RECRUITING | PHASE2 |
| NCT07490119 |
Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07474727 |
A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07468071 |
Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07441681 |
Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive Cisplatin |
NOT_YET_RECRUITING | PHASE3 |
| NCT07415031 |
A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies |
RECRUITING | PHASE2 |
| NCT07411599 |
Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out (KO) Therapy For Colorectal Cancer-Related Peritoneal Carcinomatosis: A Phase 1/2 Trial ("Chip-CRC Trial") |
RECRUITING | PHASE1/PHASE2 |
