Treatment of ARB202 Advanced Gastrointestinal Cancer Patients

Sponsor

Arbele Pty Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05411133

Collaborator

(none)

Enrollment

Locations

Arms

38.1

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to find out:

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.
To find out how study drug is broken down in the body
To know the effects of the study drug on the tumor.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer Cholangiocarcinoma Liver Cancer Colorectal Adenocarcinoma Pancreatic Cancer Gastric Cancer	Drug: ARB202	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 30, 2022

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1a: Dose Escalation	Drug: ARB202 ARB202 Atezolizumab
Experimental: Phase 1b: Low dose ARB202	Drug: ARB202 ARB202 Atezolizumab
Experimental: Phase 1b: High dose ARB202	Drug: ARB202 ARB202 Atezolizumab
Experimental: Phase 1b: Low dose ARB202 + Immune Checkpoint Inhibitor	Drug: ARB202 ARB202 Atezolizumab
Experimental: Phase 1b: High dose ARB202 + Immune Checkpoint Inhibitor	Drug: ARB202 ARB202 Atezolizumab

Outcome Measures

Primary Outcome Measures

Incidence and severity of adverse events [8 weeks post initial dose]

Secondary Outcome Measures

Amount of ARB202 in plasma after single and multiple doses of ARB202 in patients [16 weeks]
Biochemical and physiological effects of ARB202 on the amount of circulating ARB202 level in patients [16 weeks]
Biochemical and physiological effects of ARB202 on the amount of soluble CDH17 level in patients [16 weeks]
Biochemical and physiological effects of ARB202 on the amount IL-2 level in patients [16 weeks]
Effect of ARB202 on tumour as determined by changes in RECIST evaluation from baseline [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St George Private Hospital	Sydney		Australia
2	Queen Mary Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

Arbele Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arbele Pty Ltd

ClinicalTrials.gov Identifier:

NCT05411133

Other Study ID Numbers:

A001

First Posted:

Jun 9, 2022

Last Update Posted:

Jun 9, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cholangiocarcinoma

Gastrointestinal Neoplasms

Study Results

No Results Posted as of Jun 9, 2022