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OncoMatch/Clinical Trials/NCT06617858

Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment

Is NCT06617858 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies AMB-05X for colorectal cancer.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT06617858Data as of May 2026

Treatment: AMB-05XTo investigate the efficacy of AMB-05X in patients with CRC with MRD as determined by a ctDNA(+) blood test and no clinically detectable radiographic disease.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage I, II, III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: curative intent therapy

Completion of any curative intent therapies resulting in no evidence of disease (e.g., R0 resection) for stage I - IV CRC and has completed all planned adjuvant/standard therapies per the discretion of the evaluating clinician.

Cannot have received: systemic anti-cancer agents

Exception: protocol-specified anti-cancer therapy

Concurrent treatment with other systemic anti-cancer agents (e.g., chemotherapy, hormonal therapy, immunotherapy) or other treatments not part of protocol-specified anti-cancer therapy including concurrent investigational agents of any type.

Cannot have received: oral tyrosine kinase inhibitor (pexidartinib, imatinib, nilotinib)

Use of pexidartinib, any other oral tyrosine kinase inhibitor (e.g., imatinib or nilotinib), or any biologic treatment targeting CSF1 or CSF1R within the past 4 weeks.

Cannot have received: biologic treatment targeting CSF1 or CSF1R

any biologic treatment targeting CSF1 or CSF1R within the past 4 weeks.

Lab requirements

Blood counts

absolute neutrophil count: ≥1,000/mcL; platelets: ≥75,000/mcL; hemoglobin: ≥9.0 g/dL

Kidney function

Creatinine clearance ≥50 mL/min (Cockcroft-Gault equation)

Liver function

total bilirubin: ≤ institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT): ≤1.5 × institutional ULN

Adequate organ and marrow function as defined below: 1. absolute neutrophil count: ≥1,000/mcL 2. platelets: ≥75,000/mcL 3. hemoglobin: ≥9.0 g/dL 4. total bilirubin: ≤ institutional upper limit of normal (ULN) 5. AST(SGOT)/ALT(SGPT): ≤1.5 × institutional ULN 6. Creatinine clearance ≥50 mL/min. Creatinine clearance (CrCl) to be estimated by the Cockcroft-Gault equation

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

US trial sites

  • The University of Texas MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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