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Treatment of ARB202 Advanced Gastrointestinal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05411133
Recruitment Status : Recruiting
First Posted : June 9, 2022
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
Arbele Limited ( Arbele Pty Ltd )

Study Description
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Brief Summary:

This study aims to find out:

  1. 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.
  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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: 8 weeks post initial dose ]

Secondary Outcome Measures :
  1. Amount of ARB202 in plasma after single and multiple doses of ARB202 in patients [ Time Frame: 16 weeks ]
  2. Biochemical and physiological effects of ARB202 on the amount of circulating ARB202 level in patients [ Time Frame: 16 weeks ]
  3. Biochemical and physiological effects of ARB202 on the amount of soluble CDH17 level in patients [ Time Frame: 16 weeks ]
  4. Biochemical and physiological effects of ARB202 on the amount IL-2 level in patients [ Time Frame: 16 weeks ]
  5. Effect of ARB202 on tumour as determined by changes in RECIST evaluation from baseline [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥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
    • amylase < 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05411133


Contacts
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Contact: Dennis Wong, M.D +1 415 632 6596 dennis.wong@arbelebio.com

Locations
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Australia
Southern Oncology Clinical Research Unit Recruiting
Adelaide, Australia
Contact       clinicaltrials@socru.org.au   
St George Private Hospital Recruiting
Sydney, Australia
Contact: Paul de Souza       p.desouza@westernsydney.edu.au   
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Roland Leung       lcy035@ha.org.hk   
Singapore
National University Hospital Not yet recruiting
Singapore, Singapore
Contact: Wei Peng Yong         
Sponsors and Collaborators
Arbele Pty Ltd
More Information
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Responsible Party: Arbele Pty Ltd
ClinicalTrials.gov Identifier: NCT05411133    
Other Study ID Numbers: A001
First Posted: June 9, 2022    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Gastrointestinal Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases