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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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

Titles & IDs
Public title
Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients
Scientific title
A Phase 1, First-in-human Study of Cabotamig (ARB202), Bispecific Antibody to CDH17 and CD3 in Advanced Gastrointestinal Malignancies
Secondary ID [1] 0 0
A001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Cancer 0 0
Cholangiocarcinoma 0 0
Liver Cancer 0 0
Colorectal Adenocarcinoma 0 0
Pancreatic Cancer 0 0
Gastric Cancer 0 0
Esophageal Adenocarcinoma 0 0
Gastroesophageal Junction 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events
Timepoint [1] 0 0
8 weeks post initial dose
Secondary outcome [1] 0 0
Amount of Cabotamig (ARB202) in plasma after single and multiple doses of ARB202 (Cabotamig) in patients
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
Biochemical and physiological effects of Cabotamig (ARB202) on the amount of circulating ARB202 (Cabotamig) level in patients
Timepoint [2] 0 0
16 weeks
Secondary outcome [3] 0 0
Biochemical and physiological effects of Cabotamig (ARB202) on the amount of soluble CDH17 level in patients
Timepoint [3] 0 0
16 weeks
Secondary outcome [4] 0 0
Biochemical and physiological effects of Cabotamig (ARB202) on the amount IL-2 level in patients
Timepoint [4] 0 0
16 weeks
Secondary outcome [5] 0 0
Effect of Cabotamig (ARB202) on tumour as determined by changes in RECIST evaluation from baseline
Timepoint [5] 0 0
6 weeks

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Southern Oncology Clinical Research Unit - Adelaide
Recruitment hospital [2] 0 0
St George Private Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arbele Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dennis Wong, M.D
Address 0 0
Country 0 0
Phone 0 0
+1 415 632 6596
Fax 0 0
Email 0 0
dennis.wong@arbelebio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/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] 53
10/11/2021
Approval date [1] 53
18/02/2022
Ethics approval number [1] 53
2021-11-1319
 
Public notes

Contacts
Principal investigator
Title 345 0
Prof
Name 345 0
Paul de Souza
Address 345 0
St George Private Hospital 1 South Street Kogarah NSW 2217
Country 345 0
Australia
Phone 345 0
Fax 345 0
Email 345 0
Contact person for public queries
Title 346 0
Name 346 0
Address 346 0
Country 346 0
Phone 346 0
Fax 346 0
Email 346 0
Contact person for scientific queries
Title 347 0
Dr
Name 347 0
Dennis Wong
Address 347 0
Arbele Limited Unit 522, Biotech Center 2, 11 Science Park West Ave., Shatin, N.T., Hong Kong
Country 347 0
Hong Kong
Phone 347 0
Fax 347 0
Email 347 0
dennis.wong@arbelebio.com