Clinical Trials Roundup
Curated by Fight CRC’s Medical Advisory Board & Research Advocacy Training and Support (RATS) team.
This month’s roundup highlights powerful studies from ASCO GI 2026, showcasing novel therapeutic strategies for patients with microsatellite stable (MSS) colorectal cancer, KRAS G12C mutations, and refractory disease. Whether you’re looking at first-line changes or exciting third-line immunotherapy approaches, this edition offers actionable updates.
Need help understanding clinical trials or biomarker testing? See our biomarker resources here.
January 2026
1. BREAKWATER Trial — Triplet Therapy Sets New Standard for BRAF V600E mCRC
Biomarker Focus: BRAF V600E mutation
Phase / Sites: Phase 3 / Multi-national
Stage: Stage IV (metastatic)
Recruitment Status: Completed (Phase 3)
What it’s studying: Encorafenib + cetuximab + FOLFIRI vs chemotherapy in first-line mCRC
Findings: PFS nearly doubled (12.8 vs 7.1 months); OS improved to 30.3 vs 15.1 months
Why it matters: A new triplet could replace chemo as the standard for BRAF-mutated mCRC
Patient Tip: If you have BRAF V600E-mutant CRC and are starting first-line treatment, ask whether this triplet regimen is being considered.
ClinicalTrials.gov: N/A
2. ATOMIC Trial — Atezolizumab + Chemo in Stage III dMMR CRC
Biomarker Focus: Mismatch repair deficiency (dMMR / MSI-H)
Phase / Sites: Phase 3 / Multi-center
Stage: Stage III (resected)
Recruitment Status: Completed
What it’s studying: mFOLFOX6 with or without atezolizumab after surgery in stage III colon cancer
Findings: 3-year disease-free survival improved to 86.4% vs 76.6%
Why it matters: May change adjuvant therapy for early-stage dMMR CRC
Patient Tip: If your tumor is MSI-H/dMMR and you’re receiving adjuvant chemo, ask whether immunotherapy was considered or studied in your care setting.
ClinicalTrials.gov: NCT02912559
3. IVX037 + Sintilimab in MSS CRC — RNA Virus Therapy for IO-Resistant Tumors
Biomarker Focus: Microsatellite stable (MSS), KRAS mutations
Phase / Sites: Phase 1 / Single site (expansion)
Stage: Stage IV (refractory)
Recruitment Status: Expansion underway (Phase 1a complete)
What it’s studying: A bio-selected, receptor-targeted oncolytic RNA virus (IVX037) injected into tumors, combined with anti-PD-1 sintilimab
Findings: Disease control in patients with MSS and KRAS G12D CRC; early immune activation observed
Why it matters: One of the first intratumoral viral therapies showing benefit in MSS CRC: a population typically unresponsive to immunotherapy
Patient Tip: If your tumor is MSS and you’ve exhausted chemo options, ask your care team about clinical trials exploring novel immunotherapy combinations or virus-based therapies.
ClinicalTrials.gov: N/A
4. DYNAMIC-III Trial — ctDNA-Guided Escalation in Stage III CRC
Biomarker Focus: Circulating tumor DNA (ctDNA)
Phase / Sites: Phase 2 / Australia
Stage: Stage III (resected)
Recruitment Status: Completed
What it’s studying: Use of post-surgical ctDNA to guide chemotherapy intensity
Findings: Escalation based on ctDNA positivity improved outcomes; negative ctDNA patients avoided unnecessary chemo
Why it matters: Further validates ctDNA as a tool for adjuvant therapy decisions
Patient Tip: If you’ve had surgery for stage III CRC, ask if ctDNA testing could help tailor your chemotherapy plan.
ClinicalTrials.gov: NCT03803553
5. Tumor-Agnostic ADC Use in CRC – Real-World Data on KRAS G12C and HER2+ Subtypes
Biomarker Focus: KRAS G12C, HER2, and ADC-responsive profiles
Phase / Sites: Retrospective / Multiple centers
Stage: Stage IV (refractory)
Recruitment Status: Retrospective analysis of real-world patients (not an interventional trial)
What it’s studying: Outcomes among CRC patients treated with tumor-agnostic antibody-drug conjugates (ADCs) in third-line or later settings
Findings: HER2+ and KRAS G12C patients experienced stable disease or prolonged progression-free survival with investigational ADCs
Why it matters: Highlights the transition of novel ADCs from trials to practice and underscores the importance of biomarker matching in refractory mCRC
Patient Tip: If you’ve already tried standard treatments, ask your provider about biomarker testing for targets like HER2 or KRAS G12C, which may open access to novel ADC-based strategies through expanded access or real-world use.
ClinicalTrials.gov: N/A