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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05411133
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT05411133
Ethics application status
Date submitted
25/05/2022
Date registered
9/06/2022
Date last updated
23/01/2024
Titles & IDs
Public title
Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients
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Scientific title
A Phase 1, First-in-human Study of Cabotamig (ARB202), Bispecific Antibody to CDH17 and CD3 in Advanced Gastrointestinal Malignancies
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Secondary ID [1]
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A001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Cancer
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Cholangiocarcinoma
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Liver Cancer
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Colorectal Adenocarcinoma
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Pancreatic Cancer
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Gastric Cancer
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Esophageal Adenocarcinoma
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0
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Gastroesophageal Junction
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Condition category
Condition code
Cancer
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0
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Biliary tree (gall bladder and bile duct)
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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0
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cabotamig (ARB202)
Experimental: 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 -
Treatment: Drugs: Cabotamig (ARB202)
Cabotamig (ARB202), Atezolizumab
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence and severity of adverse events
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Assessment method [1]
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Timepoint [1]
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8 weeks post initial dose
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Secondary outcome [1]
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Amount of Cabotamig (ARB202) in plasma after single and multiple doses of ARB202 (Cabotamig) in patients
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Assessment method [1]
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Timepoint [1]
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16 weeks
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Secondary outcome [2]
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Biochemical and physiological effects of Cabotamig (ARB202) on the amount of circulating ARB202 (Cabotamig) level in patients
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Assessment method [2]
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Timepoint [2]
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16 weeks
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Secondary outcome [3]
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Biochemical and physiological effects of Cabotamig (ARB202) on the amount of soluble CDH17 level in patients
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Assessment method [3]
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0
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Timepoint [3]
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16 weeks
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Secondary outcome [4]
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Biochemical and physiological effects of Cabotamig (ARB202) on the amount IL-2 level in patients
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Assessment method [4]
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0
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Timepoint [4]
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16 weeks
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Secondary outcome [5]
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Effect of Cabotamig (ARB202) on tumour as determined by changes in RECIST evaluation from baseline
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Assessment method [5]
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Timepoint [5]
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6 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2025
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Actual
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Sample size
Target
68
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Southern Oncology Clinical Research Unit - Adelaide
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Recruitment hospital [2]
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St George Private Hospital - Sydney
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Sydney
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Hong Kong
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Arbele Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study aims to find out:
1. The tolerability of Cabotamig (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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05411133
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dennis Wong, M.D
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Address
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Country
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Phone
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+1 415 632 6596
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05411133
Additional trial details provided through ANZCTR
Accrual to date
1
Recruiting in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1]
99
2217
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Arbele Pty Ltd
Primary sponsor address
Level 32, 101 Miller Street, North Sydney, NSW, Australia 2060
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1]
53
Bellberry Human Research Ethics Committee
Address [1]
53
123 Glen Osmond Road Eastwood South Australia 5063
Country [1]
53
Australia
Date submitted for ethics approval [1]
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10/11/2021
Approval date [1]
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18/02/2022
Ethics approval number [1]
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2021-11-1319
Public notes
Contacts
Principal investigator
Title
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Prof
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Name
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Paul de Souza
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Address
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St George Private Hospital 1 South Street Kogarah NSW 2217
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Country
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Australia
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Phone
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Fax
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Email
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Contact person for public queries
Title
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Name
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Address
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Phone
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Email
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Contact person for scientific queries
Title
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Dr
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Name
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Dennis Wong
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Address
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Arbele Limited Unit 522, Biotech Center 2, 11 Science Park West Ave., Shatin, N.T., Hong Kong
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Country
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Hong Kong
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Phone
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Fax
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Email
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[email protected]
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