5 New Colorectal Cancer Clinical Trials to Know About

Clinical trials are how researchers learn whether new treatments are safe and whether they work better than current options. Phase 1 trials focus on safety and dosing in small groups of people, phase 2 trials look at whether a treatment works and phase 3 trials compare a new treatment with the standard of care, often to support approval from the Food and Drug Administration (FDA). Here are five colorectal cancer trials that recently began treating patients.

1. How Could SOT109 Deliver Treatment Directly to Colorectal Cancer Cells?

On Sept. 10, SOTIO announced that the first patient received SOT109 in the phase 1/2 CADENCIA-01 trial. The study is enrolling people with advanced colorectal cancer that cannot be removed with surgery or has spread.

SOT109 is an antibody-drug conjugate, or ADC. ADCs work like a guided delivery system: An antibody finds a specific marker on cancer cells, in this case a protein called CDH17, and delivers a cancer-killing drug directly to them. This may help spare healthy cells. The FDA granted SOT109 fast track designation in July, a status meant to speed the development of promising drugs.

2. Can CT-202 Help When Colorectal Cancer Stops Responding to Treatment?

On Sept. 9, Context Therapeutics announced that it had treated the first patient in a phase 1 trial of CT-202. The treatment targets Nectin-4, a protein found on the surface of some tumor cells.

The trial is enrolling people whose colorectal, bladder or triple-negative breast cancer has come back, spread or stopped responding to other treatments. Because this is an early trial, its main goal is to learn whether CT-202 is safe and what dose works best.

3. Could Cadonilimab Before and After Surgery Help People With MSI-High Colon Cancer?

On Oct. 10, Akeso announced that the first patient was treated in a phase 3 trial of cadonilimab given before and after surgery in people with colon cancer that can be surgically removed.

The trial focuses on tumors that are MSI-high or dMMR, meaning they have a genetic feature that affects how cells repair damaged DNA. These tumors often respond well to immunotherapy. Cadonilimab is an immunotherapy that releases two “brakes” on the immune system, called PD-1 and CTLA-4, to help immune cells attack cancer.

4. Can Spevatamig Help the Immune System Find Hidden Cancer Cells?

Phanes Therapeutics announced on Oct. 14 that the first patient with colorectal cancer received spevatamig in the phase 1/2 TWINPEAK trial, which is also studying the drug in other advanced digestive tract cancers.

Spevatamig is a bispecific antibody, meaning it can latch onto two targets at once. One is claudin 18.2, a protein on some cancer cells. The other is CD47, a “don’t eat me” signal that cancer cells use to hide from the immune system. Blocking that signal may help immune cells find and destroy the tumor.

5. Could Pairing AN4035 With Cetuximab Target RAS-Driven Colorectal Cancer?

On Oct. 15, Adlai Nortye announced agreements with Eli Lilly and Merck KGaA, Darmstadt, Germany, to test its experimental ADC, AN4035, together with cetuximab (Erbitux). Cetuximab is already approved to treat some colorectal cancers. The combination will be studied within an ongoing global phase 1 trial.

AN4035 targets CEACAM5, a protein common on colorectal cancer cells. It carries a drug designed to block RAS, a family of proteins that, when changed, can help drive cancer growth.

What Do These Trials Mean for People With Colorectal Cancer?

These trials are at different stages, and it will take time to learn whether any of these treatments work better than current options. Patients interested in joining a clinical trial should ask their care team whether they may be eligible. Trials can also be searched at ClinicalTrials.gov.

References

1. SOTIO. “SOTIO Doses First Patient in Phase 1/2 CADENCIA-01 Clinical Trial of SOT109, a CDH17-Targeting ADC for Colorectal Cancer.” Sept. 10, 2026.
2. SOTIO. “FDA Grants Fast Track Designation to SOTIO’s SOT109, a CDH17-targeting ADC for Colorectal Cancer.” July 14, 2026.
3. Context Therapeutics. “Context Therapeutics Announces First Patient Dosed in Phase 1 Trial of CT-202.” Sept. 9, 2026.
4. Akeso, Inc. “First Patient Dosed in Phase III Perioperative Study of Cadonilimab (PD-1/CTLA-4) in Colon Cancer.” Oct. 10, 2026.
5. Phanes Therapeutics. “Phanes Therapeutics Announces First Patient With Colorectal Cancer (CRC) Dosed in Clinical Study of Spevatamig.” Oct. 14, 2026.
6. Adlai Nortye. “Adlai Nortye Enters Into Clinical Collaboration With Lilly and Merck KGaA, Darmstadt, Germany to Evaluate Combination of AN4035 and Cetuximab.” Oct. 15, 2026.

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