Treatment Of Cabotamig (ARB202) In Advanced Gastrointestinal Cancer Patients

Study Overview

Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients

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.

N/A

Gastrointestinal Cancer
Cholangiocarcinoma
Liver Cancer
Colorectal Adenocarcinoma
Pancreatic Cancer
Gastric Cancer
Esophageal Adenocarcinoma
Gastroesophageal Junction
Gastrointestinal Neuroendocrine Tumors

DRUG: Cabotamig (ARB202)

A001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-05-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-28
First Submitted that Met QC Criteria 2022-06-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-04
First Posted (ESTIMATED) 2022-06-09	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase 1a: Dose Escalation	DRUG: Cabotamig (ARB202) Cabotamig (ARB202), Atezolizumab
EXPERIMENTAL: Phase 1b: Low dose Cabotamig (ARB202)	DRUG: Cabotamig (ARB202) Cabotamig (ARB202), Atezolizumab
EXPERIMENTAL: Phase 1b: High dose Cabotamig (ARB202)	DRUG: Cabotamig (ARB202) Cabotamig (ARB202), Atezolizumab
EXPERIMENTAL: Phase 1b: Low dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor	DRUG: Cabotamig (ARB202) Cabotamig (ARB202), Atezolizumab
EXPERIMENTAL: Phase 1b: High dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor	DRUG: Cabotamig (ARB202) Cabotamig (ARB202), Atezolizumab

Primary Outcome Measures	Measure Description	Time Frame
Incidence and severity of adverse events		8 weeks post initial dose

Secondary Outcome Measures	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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Dennis Wong, M.D

Phone Number: +1 415 632 6596

Email: dennis.wong@arbelebio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record