Every year, the American Society of Clinical Oncology (ASCO) Annual Meeting brings groundbreaking research to the forefront — and this year is no exception. At ASCO 2025, several clinical trials offer renewed hope for those impacted by colorectal cancer (CRC). From first-in-class therapies to smarter, more targeted treatment strategies, the future of CRC care is being shaped in real time.

Here’s a roundup of some of the most exciting CRC trials in progress that caught our attention.

• Trial Basics: Recruiting, phase 1/ 2 trial (NCT05919264)
• What’s new: FOG-001 is a first-in-class direct β-catenin inhibitor, targeting a pathway long considered undruggable — the Wnt/β-catenin signaling cascade, which drives tumor growth in many CRC cases.
• Why it matters: This is the first drug of its kind in the clinic, aiming to intercept a key mechanism of cancer progression.
• Who it’s for: Patients with locally advanced or metastatic microsatellite stable (MSS) CRC, as well as other solid tumors.
• Learn more: Abstract TPS3169

• Trial Basics: Active, no longer recruiting phase 1/2 clinical trial (NCT04440735)
• What’s new: DSP107 is a bi-specific fusion protein targeting CD47 on cancer cells and 41BB on immune cells, helping the immune system find and fight cancer cells.
• Why it matters: This first-in-class drug could offer a much-needed immunotherapy option for MSS mCRC – a cancer type that is typically resistant to current immunotherapy treatments.
• Who it’s for: Patients with MSS mCRC, as well as other solid tumors.
• Learn more: Abstract 3517

• Trial Basics: Recruiting, phase 3 clinical trial (NCT06614192)
• What’s new: Temab-A is an antibody-drug conjugate (ADC) designed to precisely target c-Met–positive tumors — essentially delivering chemo directly to the cancer like a guided missile.
• Why it matters: This trial pits Temab-A against a current standard regimen (trifluridine/tipiracil (LONSURF)+ bevacizumab), offering new hope for those with treatment-resistant (refractory) metastatic CRC (mCRC).
• Who it’s for: Patients with high c-Met expression and refractory mCRC.
• Learn more: Abstract TPS3635

• Trial Basics: Phase 3 clinical trial (NCT02912559)
• What’s new: The ATOMIC clinical trial is set to determine whether adding atezolizumab, an immunotherapy, to combination chemotherapy can improve outcomes for patients with stage III mismatch repair-deficient (dMMR) colon cancer.
• Why it matters: This trial compares adjuvant FOLFOX chemotherapy with or without atezolizumab, offering new hope for patients with stage III dMMR colon cancer by potentially reducing recurrence and improving cure rates in a biomarker-defined, high-risk early-stage population.
• Learn more: Abstract LBA1

• Trial Basics: Recruiting, phase 3 clinical trial (NCT05673148)
• What’s new: The ERASur trial explores total ablative therapy — including radiation, ablation, and surgery — for patients with limited metastatic CRC.
• Why it matters: This “curative intent” strategy may shift how we treat oligometastatic CRC, emphasizing local control of disease even in metastatic settings.
• Learn more: Abstract TPS3634
• Read more about this trial from Fight CRC and ERASur principal investigator (PI), Dr. Eric Miller, a GI radiation oncologist at The Ohio State University Comprehensive Cancer Center, here!

• Trial Basics: Observational/Translational
• What’s new: This study gathers real-world evidence and aims to identify biomarkers for fruquintinib use in metastatic CRC.
• Why it matters: Biomarker research is key to personalizing CRC care. Fruquintinib was recently approved, and this trial will help guide its future use.
• Learn more: Abstract TPS3637

• Trial Basics: Phase 3, placebo-controlled clinical trial (NCT03326791)
• What’s new: The ASAC trial is investigating whether low-dose aspirin can improve disease-free survival in patients treated for colorectal cancer liver metastases (CRCLM).
• Why it matters: If proven beneficial, aspirin could be an inexpensive, well-tolerated, and easily accessible option for secondary prevention of CRCLM.
• Learn more: Abstract LBA3511

• Trials to watch:
  • VALENTINO Trial: Evaluates low-pass whole methylome sequencing as a noninvasive method for monitoring metastatic CRC. (Abstract 3552)
  • ꞵ-CORRECT Study: Investigates the relationship between circulating tumor DNA (ctDNA) and recurrence risk in stage II-IV CRC. (Abstract 3590)
• Why it matters: These studies could make blood-based testing a routine tool for early relapse detection, leading to faster interventions and more personalized treatment strategies.

Several ASCO 2025 trials explored innovative combinations of immunotherapy and targeted therapy. Notable mentions include:

• Second-generation KRAS G12C inhibitor: Combining olomorasib and cetuximab in advanced KRAS G12C-mutant CRC (Abstract 3507)
• SPARKLE-L: Combining stereotactic body radiation therapy (SBRT) with a PD-1 inhibitor in unresectable CRC liver metastases. (Abstract TPS3639)
• GCC19CART Study: First-in-human study of a CAR T-cell therapy in mCRC. (Abstract 3581)
• Phase 1b Vaccine Trial: Using a mutant KRAS peptide vaccine + dual checkpoint inhibitors in MMR-proficient CRC. (Abstract TPS2698)

These trials are pushing the boundaries of immunotherapy in colorectal cancer — especially for patients previously considered ineligible for such treatments.

The ASCO 2025 lineup shows that innovation in colorectal cancer research is accelerating — with therapies that are:

• More precise and biomarker-driven
• Designed for treatment-resistant or metastatic disease
• Focused on patient-centered outcomes like quality of life, minimal toxicity, and early detection

At Fight CRC, we’re inspired by the momentum and remain committed to keeping the community informed, empowered, and engaged.

Stay tuned for updates as these trials progress — and as always, talk to your doctor about whether a clinical trial might be right for you.

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