Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients

January 22, 2024 updated by: Arbele Pty Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 1

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

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events
Time Frame: 8 weeks post initial dose
8 weeks post initial dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Amount of Cabotamig (ARB202) in plasma after single and multiple doses of ARB202 (Cabotamig) in patients
Time Frame: 16 weeks
16 weeks
Biochemical and physiological effects of Cabotamig (ARB202) on the amount of circulating ARB202 (Cabotamig) level in patients
Time Frame: 16 weeks
16 weeks
Biochemical and physiological effects of Cabotamig (ARB202) on the amount of soluble CDH17 level in patients
Time Frame: 16 weeks
16 weeks
Biochemical and physiological effects of Cabotamig (ARB202) on the amount IL-2 level in patients
Time Frame: 16 weeks
16 weeks
Effect of Cabotamig (ARB202) on tumour as determined by changes in RECIST evaluation from baseline
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

Arbele Pty Ltd

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 Major Dates

Study Start (Actual)

May 30, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

June 5, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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