Also known as: metastatic CRC
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.
Pfizer reported new clinical and regulatory milestones across oncology, obesity and hemophilia, including BREAKWATER Phase 3 data and Priority Review for HYMPAVZI. The company also cited MagnetisMM-5 results and FDA priority review for PADCEV.
Adagene and Incyte will collaborate on a Phase 1 study combining muzastotug with INCA33890 for MSS colorectal cancer patients, beginning in 2026. The collaboration marks the second instance where Adagene's SAFEbody technology is paired with a PD-1-based bispecific. Muzastotug has shown encouraging response rates in combination with pembrolizumab in previous trials.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in KRAS-mutant colorectal cancer based on data showing 33% response rate and 27-month median survival. The company is launching a Phase 2 study and recently completed reincorporation from Canada to Nevada. This marks the second Fast Track Designation for pelareorep in gastrointestinal cancers.
Iterion Therapeutics has dosed the first patient in a phase 1/2 trial of its Wnt/β-catenin inhibitor tegavivint for metastatic colorectal cancer. The expansion builds on promising monotherapy activity observed in advanced hepatocellular carcinoma, targeting a pathway activated in over 90% of colorectal cancer patients.
Colorectal cancer diagnoses in people under 50 now account for nearly half of all new cases, prompting specialized treatment programs that use precision medicine and liquid biopsy technology to customize care based on individual tumor genetics.
Colorectal cancer rates are rising 3% annually in adults under 50, prompting expanded screening efforts and new treatment approaches. Recent research shows promise in combination immunotherapy and vaccine strategies for advanced disease.
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.
Liquid biopsy-based circulating tumour DNA analysis has evolved from single-gene testing to comprehensive genomic profiling, enabling detection of actionable targets and minimal residual disease in colorectal cancer patients.
Oncolytics Biotech launches Phase 2 trial of pelareorep immunotherapy in metastatic colorectal cancer, following Fast Track Designation and promising earlier results showing 27-month median survival.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07559760 |
New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer |
RECRUITING | PHASE2 |
| NCT07549412 |
A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03) |
RECRUITING | PHASE3 |
| NCT07543744 |
A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI |
RECRUITING | PHASE1 |
| NCT07503756 |
JS212 Combination Therapies in Metastatic Colorectal Cancer |
RECRUITING | PHASE2 |
| NCT07416552 |
A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) |
RECRUITING | PHASE1 |
| NCT07359456 |
Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases |
NOT_YET_RECRUITING | PHASE2 |
| NCT07318389 |
ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07314294 |
Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients |
RECRUITING | PHASE2 |
| NCT07277322 |
Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07263178 |
A Study of Second- and Later-line Palliative Chemotherapy in Patients With Metastatic Colorectal Cancer. |
RECRUITING |
