ABL111 received FDA agreement on an accelerated approval pathway for metastatic gastric cancer as the first patient was dosed in a global phase 2 trial. The companies said ORR will support accelerated approval and phase 2 is evaluating ABL111 with nivolumab and mFOLFOX6.
AstraZeneca will report pivotal first-half data on sonesitatug vedotin in Claudin18.2 gastric cancer. The phase 3 Clarity-Gastric01 study is enrolling patients with ≥25% expression.
Atezolizumab combined with chemotherapy shows significant benefits in dMMR/MSI-H colorectal cancer. In stage III disease, the ATOMIC trial demonstrated improved 3-year DFS (86.3% vs 76.2%) with atezolizumab plus mFOLFOX6. For metastatic disease, the COMMIT trial showed superior PFS (24.5 vs 5.3 months) with atezolizumab, bevacizumab, and FOLFOX versus atezolizumab monotherapy.
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.
NovaBridge Biosciences has enrolled the first patient in a global Phase 2 study evaluating givastomig in combination with nivolumab and chemotherapy for HER2-negative, first-line metastatic gastric cancer, with top-line results expected in 2027.
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 |
|---|---|---|---|
| NCT07543471 |
A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | PHASE1 |
| NCT07381400 |
Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study) |
NOT_YET_RECRUITING | PHASE2 |
| NCT06959693 |
A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC) |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT06890624 |
mFOLFOXIRI Plus PD-1 Inhibitor vs mFOLFOX6 as Neoadjuvant Therapy for Locally Advanced Colon Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT06812728 |
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients |
RECRUITING | PHASE2 |
| NCT06791512 |
mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Vs. mFOLFOX6 in Locally Advanced pMMR/MSS CRC |
RECRUITING | PHASE3 |
| NCT06650332 |
Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients |
RECRUITING | PHASE1/PHASE2 |
| NCT06324357 |
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread |
RECRUITING | PHASE1/PHASE2 |
| NCT06162650 |
Total Neoadjuvant Therapy in Rectal Cancer |
RECRUITING | PHASE2 |
| NCT05673772 |
Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer |
ACTIVE_NOT_RECRUITING | PHASE2 |
