Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients

Pancreatic Cancer Clinical Trial

Official title:

A Phase 1, First-in-human Study of Cabotamig (ARB202), Bispecific Antibody to CDH17 and CD3 in Advanced Gastrointestinal Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411133
• Other study ID #: A001
• Status: Recruiting
• Phase: Phase 1
• Start date: May 30, 2022
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Arbele Limited
• Contact: Dennis Wong, M.D
• Phone: +1 415 632 6596
• Email: dennis.wong[@]arbelebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: August 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Cholangiocarcinoma
• Colorectal Adenocarcinoma
• Esophageal Adenocarcinoma
• Gastric Cancer
• Gastroesophageal Junction
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Liver Cancer
• Pancreatic Cancer

Intervention

Drug:
• Cabotamig (ARB202)
Cabotamig (ARB202), Atezolizumab

Locations

Country	Name	City	State
Australia	Southern Oncology Clinical Research Unit	Adelaide
Australia	St George Private Hospital	Sydney
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Arbele Pty Ltd

Countries where clinical trial is conducted

Australia,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events		8 weeks post initial dose
Secondary	Amount of Cabotamig (ARB202) in plasma after single and multiple doses of ARB202 (Cabotamig) in patients		16 weeks
Secondary	Biochemical and physiological effects of Cabotamig (ARB202) on the amount of circulating ARB202 (Cabotamig) level in patients		16 weeks
Secondary	Biochemical and physiological effects of Cabotamig (ARB202) on the amount of soluble CDH17 level in patients		16 weeks
Secondary	Biochemical and physiological effects of Cabotamig (ARB202) on the amount IL-2 level in patients		16 weeks
Secondary	Effect of Cabotamig (ARB202) on tumour as determined by changes in RECIST evaluation from baseline		6 weeks