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OncoMatch/Clinical Trials/NCT06225843

Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis

Is NCT06225843 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sotevtamab and FOLFOX for metastatic colorectal cancer.

Phase 2RecruitingAlethia BiotherapeuticsNCT06225843Data as of May 2026

Treatment: Sotevtamab · FOLFOXThis Phase II study will recruit 17 colorectal cancer patients with liver-dominant metastases. All recruited patients will receive Sotevtamab at a dose of 800 mg once weekly for 6 cycles combined with FOLFOX once every 2 weeks for the first 4 cycles followed by liver metastases resection surgery with or without primary cancer resection. One cycle of treatment will consist of 14 days (2 weeks).

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Excluded: MMR deficient

Participants with MMR-deficient primary colorectal tumor

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: sotevtamab (sotevtamab)

Participants who have received prior therapy with sotevtamab

Cannot have received: chemotherapy for metastatic disease

Exception: Prior adjuvant chemotherapy and radiotherapy following resection of primary tumor is acceptable if completed at least 12 months prior to trial enrolment.

Participants must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy and radiotherapy following resection of primary tumor is acceptable if completed at least 12 months prior to trial enrolment.

Lab requirements

Blood counts

adequate organ and immune function

Kidney function

adequate organ and immune function

Liver function

adequate organ and immune function

Participants must have adequate organ and immune function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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