New hope for advanced gut cancers? early trial tests targeted antibody
NCT ID NCT05411133
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug called cabotamig in 33 adults with advanced cancers of the digestive system (like colon, pancreas, or liver) that had stopped responding to standard treatments. The goal was to see if the drug is safe and how it affects the body and tumors. Participants needed to have a specific marker (CDH17) on their cancer cells.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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33 people
The number who actually took part.
- Started
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May 2022
- Finished
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Jul 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed colorectal, pancreatic, gastric adenocarcinoma, primary liver cancer or metastatic liver disease, or cholangiocarcinoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * Malignancies should possess with ≥10% expression of CDH17 confirmed by immunohistochemistry except for CRC patients. If the testing is based on fine-needle aspiration (FNA) biopsy, the patient will be considered eligible when tumor aspirate demonstrates detectable positive staining cells for CDH17. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. * Life expectancy \> 3 months. * Measurable disease as defined by RECIST 1.1 criteria * Blood coagulation parameters: * PT INR ≤ 1.5X ULN * PTT INR ≤1.2X ULN * Patients must have adequate venous peripheral access for apheresis. * Satisfactory organ and bone marrow function as defined by: * absolute neutrophil count \> 1,000/μL * platelets \>100,000/μL * hemoglobin ≥9 g/dL * serum ALT and AST ≤ 3X ULN or AST and ALT ≤5X ULN, if liver function abnormalities are thought to be from underlying malignancy * total serum bilirubin ≤ 2X ULN * Creatinine \<1.5X ULN * Stable amylase for 2 weeks Exclusion Criteria: * Prior gene therapy or therapy with any murine monoclonal antibodies or any murine containing product. * Concurrent treatment with any anticancer agent including chemotherapy, hormonal therapy or radiation therapy. Must be 5 X half-life or 6 weeks (whichever is shorter) post dosing of previous cancer therapies. * History of allergy or hypersensitivity to murine proteins or study product excipients * Females who are pregnant, trying to become pregnant, or breastfeeding. * Diagnosis of HIV or chronic active viral hepatitis (HBV, HCV, HIV). * Active infection requiring systemic treatment. * Active brain, leptomeningeal, or paraspinal metastases, except for asymptomatic metastases and are stable on a steroid dose of ≤ 10mg/day of prednisone or its equivalent for at least 14 days prior to the start of study interventions. * Impaired cardiac function (AHA NY Heart Association Grade II-IV) or clinically significant cardiac disease. * Lack of recovery of prior CTCAE Grade 3 or above adverse events due to earlier therapies. * Chronic use of corticosteroids in excess of \>10mg daily of prednisone or equivalent within 4 weeks prior to alopecia. * Concomitant use of complementary or alternative medication or therapy such as Chinese herbal medicine. * History of Crohn's disease, inflammatory bowel disease, or ulcerative colitis within the past 5 years * Abnormal bowel function which would make assessment of bowel permeability difficult to access * Major trauma or major surgery within 4 weeks prior to first dose of study drug
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Queen Mary Hospital
Hong Kong, Hong Kong
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Southern Oncology Clinical Research Unit
Adelaide, Australia
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St George Private Hospital
Sydney, Australia
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Other studies related to the condition(s) this trial covers.
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