Treatment of Cabotamig in patients with advanced gastrointestinal cancer
A Phase 1, First-in-human Study of Cabotamig (ARB202), Bispecific Antibody to CDH17 and CD3 in Advanced Gastrointestinal Malignancies
This study tests a new drug called Cabotamig to see if it is safe and effective for adults with advanced gastrointestinal cancer that hasn't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Arbele Limited Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 3 sites (Adelaide and 2 other locations) |
| Trial ID | NCT05411133 on ClinicalTrials.gov |
What this trial studies
This study evaluates the tolerability of Cabotamig (ARB202) in adults with advanced solid gastrointestinal tumors who have not responded to standard treatments. Participants must have tumors expressing the CDH17 marker and will be monitored for how the drug is metabolized in the body and its effects on the tumor. The study aims to provide insights into the safety and efficacy of this new treatment option for patients with specific types of gastrointestinal cancers.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced colorectal, pancreatic, gastric adenocarcinoma, primary liver cancer, or cholangiocarcinoma that is metastatic or unresectable.
Not a fit: Patients whose tumors do not express the CDH17 marker or who have not met the specified health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced gastrointestinal cancers who have limited alternatives.
How similar studies have performed: While this approach is novel, similar studies targeting specific biomarkers in advanced cancers have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * 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
Where this trial is running
Adelaide and 2 other locations
- Southern Oncology Clinical Research Unit — Adelaide, Australia (Recruiting)
- St George Private Hospital — Sydney, Australia (Recruiting)
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Dennis Wong, M.D
- Email: dennis.wong@arbelebio.com
- Phone: +1 415 632 6596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.