Treatment of ARB202 Advanced Gastrointestinal Cancer Patients

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to find out:

1. The tolerability of ARB202 in adults with advanced solid gastrointestinal tumors who failed the standard treatment. People can participate if their tumor has the CDH17 marker.

2. To find out how study drug is broken down in the body

3. To know the effects of the study drug on the tumor.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbele Pty Ltd

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 by immunohistochemistry.

• 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 ≥90 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

• amylase < institutional ULN

• lipase < institutional ULN

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.

• Patients on anticoagulant therapy excluding low-dose aspirin (<100 mg/daily)

• Diagnosis of HIV or chronic active viral hepatitis (HBV, HCV, HIV).

• Active infection requiring systemic treatment.

• Brain, leptomeningeal, or paraspinal metastases.

• 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