Brief Title
Treatment of ARB202 Advanced Gastrointestinal Cancer Patients
Official Title
A Phase 1, First-in-human Study of ARB202, Bispecific Antibody to CDH17 and CD3 in Advanced Gastrointestinal Malignancies
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence and severity of adverse events
Secondary Outcome
Amount of ARB202 in plasma after single and multiple doses of ARB202 in patients
Condition
Gastrointestinal Cancer
Intervention
ARB202
Study Arms / Comparison Groups
Phase 1a: Dose Escalation
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
68
Start Date
May 30, 2022
Completion Date
August 2025
Primary Completion Date
November 2024
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +1 415 632 6596, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT05411133
Organization ID
A001
Responsible Party
Sponsor
Study Sponsor
Arbele Pty Ltd
Study Sponsor
, ,
Verification Date
June 2022