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This study aims to find out:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: Dose Escalation | Experimental |
| |
| Phase 1b: Low dose Cabotamig (ARB202) | Experimental |
| |
| Phase 1b: High dose Cabotamig (ARB202) | Experimental |
| |
| Phase 1b: Low dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor | Experimental |
| |
| Phase 1b: High dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabotamig (ARB202) | Drug | Cabotamig (ARB202), Atezolizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | 8 weeks post initial dose |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Cabotamig (ARB202) in plasma after single and multiple doses of ARB202 (Cabotamig) in patients | 16 weeks | |
| Biochemical and physiological effects of Cabotamig (ARB202) on the amount of circulating ARB202 (Cabotamig) level in patients | 16 weeks |
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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:
Patients must have adequate venous peripheral access for apheresis.
Satisfactory organ and bone marrow function as defined by:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Oncology Clinical Research Unit | Adelaide | Australia | ||||
| St George Private Hospital |
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| Biochemical and physiological effects of Cabotamig (ARB202) on the amount of soluble CDH17 level in patients | 16 weeks |
| Biochemical and physiological effects of Cabotamig (ARB202) on the amount IL-2 level in patients | 16 weeks |
| Effect of Cabotamig (ARB202) on tumour as determined by changes in RECIST evaluation from baseline | 6 weeks |
| Sydney |
| Australia |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D018281 | Cholangiocarcinoma |
| D008113 | Liver Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D013274 | Stomach Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013272 | Stomach Diseases |
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