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Study of ISU104, Targeting ERBB3 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03552406
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
ISU Abxis Co., Ltd.

Brief Summary:
A phase I, open-label, dose-finding study to assess the safety, tolerability and pharmacokinetics of ISU104, a human monoclonal antibody targeting erbB3 in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Biological: ISU104 Phase 1

Detailed Description:

This study ams to evaluate the safety, tolerability, and pharmacokinetics of ISU104 in patients with advanced solid tumors.

Primary objective To determine recommended Phase II dose (RP2D) of ISU104 based on the results of its safety and tolerability in patients with advanced solid tumors.

Secondary objectives

  1. To evaluate the pharmacokinetics (PK) of ISU104 in patients with advanced solid tumors.
  2. To evaluate tumor response profile of ISU104 in patients with advanced solid tumors.

Exploratory purpose To identify the expression of explorable multiple tumor biomarkers and to analyze the relationship between these biomarkers and antitumor activity.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability and Pharmacokinetics of ISU104, a Human Monoclonal Antibody Targeting ErbB3 in Patients With Advanced Solid Tumors
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : December 14, 2020

Arm Intervention/treatment
Experimental: Dose-Escalation of ISU104 (Dose-Level 1)
1 mg/kg; Administered single-dose first week and observation for 4-weeks and then Administered once weekly in a 28-days Cycle
Biological: ISU104
Intravenous Infusion for 1 hour.
Other Name: A human monoclonal antibody targeting ErbB3

Experimental: Dose-Escalation of ISU104 (Dose-Level 2)
3 mg/kg; Administered single-dose first week and observation for 4-weeks and then Administered once weekly in a 28-days Cycle
Biological: ISU104
Intravenous Infusion for 1 hour.
Other Name: A human monoclonal antibody targeting ErbB3

Experimental: Dose-Escalation of ISU104 (Dose-Level 3)
5 mg/kg; Administered single-dose first week and observation for 4-weeks and then Administered once weekly in a 28-days Cycle
Biological: ISU104
Intravenous Infusion for 1 hour.
Other Name: A human monoclonal antibody targeting ErbB3

Experimental: Dose-Escalation of ISU104 (Dose-Level 4)
10 mg/kg; Administered single-dose first week and observation for 4-weeks and then Administered once weekly in a 28-days Cycle
Biological: ISU104
Intravenous Infusion for 1 hour.
Other Name: A human monoclonal antibody targeting ErbB3

Experimental: Dose-Escalation of ISU104 (Dose-Level 5)
20 mg/kg; Administered single-dose first week and observation for 4-weeks and then Administered once weekly in a 28-days Cycle
Biological: ISU104
Intravenous Infusion for 1 hour.
Other Name: A human monoclonal antibody targeting ErbB3

Experimental: Dose-Expansion of ISU104
Selected dose during Dose-Escalation Part; Administered once weekly in a 28-days Cycle
Biological: ISU104
Intravenous Infusion for 1 hour.
Other Name: A human monoclonal antibody targeting ErbB3




Primary Outcome Measures :
  1. Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities [ Time Frame: From date of first dose to 4 weeks after administration. ]
    Determination of MTD is dependent upon number of cohorts and patients required


Secondary Outcome Measures :
  1. Toxicity Evaluation [ Time Frame: through the study completion, an average of 1 year ]
    To determine the occurrence of Adverse Events (AEs)

  2. Determine Immunogenicity of ISU104 [ Time Frame: through the study completion, an average of 1 year ]
    To measure the level of Anti-Drug Antibody (ADA) and/or Neutralizing Antibody (NAb) of ISU104

  3. Determine the Peak Plasma Concentration (Cmax) of ISU104 [ Time Frame: up to 12 weeks ]
    To measure the Peak Plasma Concentration (Cmax) of ISU104

  4. Determine the Area Under the Curve (AUC) of ISU104 [ Time Frame: up to 12 weeks ]
    To measure the Area under the plasma concentration versus time curve (AUC) of ISU104

  5. Explore Overall Response Rate (ORR) of ISU104 [ Time Frame: up to progression, an average 6 months ]
    To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >30% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline

  6. Explore Disease Control Rate (DCR) of ISU104 [ Time Frame: up to progression, an average 6 months ]
    To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >30% decrease in tumor burden from baseline, a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline, and Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Partial Response (defined as >20% decrease in tumor burden from baseline)

  7. Explore Progression-Free Survival (PFS) of ISU104 [ Time Frame: up to progression, an average 6 months ]
    To measure the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Common

  1. Male or Female with ≥ 19 years of age
  2. Histologically or Cytologically confirmed a diagnosis of an advanced solid tumor that was refractory to standard treatment or for which no standard therapy existed, or patients declined any treatment options
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  4. Life Expectancy ≥ 12 weeks
  5. Adequate Hematological, Renal and Hepatic function
  6. According to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1, the patient had at least one measurable lesion

Exclusion Criteria:

  1. Severe hypersensitivity or a history of any hypersensitivity to the similar drug class of IP
  2. Patients underwent the major surgery or procedure, or had the medical history (as blow):

    • Major surgery requiring systemic anesthesia or respiratory assist device within 4 weeks prior to baseline [2 weeks in case of video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery)]
    • Severe cardiovascular disease within 24 weeks prior to baseline
    • Severe cerebrovascular disease within 24 weeks prior to baseline
    • Pulmonary thromboembolism, deep vein thrombosis (DVT) or other clinically and significantly severe lung disease within 24 weeks prior to baseline
  3. Patients had the following concurrent diseases at baseline:

    • Hematologic malignancies including lymphoma
    • Clinically significant symptom or uncontrolled central nervous system (CNS) or brain metastases
    • Pleural effusion and ascites drainage
    • Uncontrolled hypertension (SBP/DBP > 160/100 mmHg)
    • Active hepatitis B or C virus
    • Human immunodeficiency virus (HIV) that is positive
    • Thromboembolic disease or bleeding diatheses
    • Interstitial lung disease (ILD)
  4. Left ventricular ejection fraction (LVEF) value, when measured by echocardiogram, multiple gated acquisition (MUGA) scan or a standard procedure in the institution within 4 weeks prior to the study entry
  5. Patients with the following medication history:

    • anti-ErbB3 targeted therapies
    • small-molecule tyrosine kinase inhibitors within 2 weeks prior to baseline
    • any anti-cancer therapy, including chemotherapy, radiotherapy, biologic therapy, retinoid therapy, or therapeutic/palliative radiotherapy for the treatment of advanced solid tumors within 4 weeks prior to baseline
    • Granulocyte-Colony Stimulating Factor (G-CSF), packed red cell or platelet transfusion within 2 weeks prior to the first injection of IP to correct the abnormal values of absolute neutrophil count (ANC) or platelet count
  6. Pregnant woman, breastfeeding woman, or women of childbearing age and men with partners of childbearing age, unless they are willing to follow abstinence or use effective forms of contraception* from the study entry until at least 16 weeks after the EOT visit
  7. Subjects receiving any other investigational products or medical devices within 4 weeks prior to screening
  8. Principal investigator's opinion

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): NCT03552406


Contacts
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Contact: Jinsun Yang +82 31 696 4753 yjs3700@isu.co.kr

Locations
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Korea, Republic of
Kosin University Gospel Hospital Recruiting
Busan, Korea, Republic of
Contact: Seong-Hoon Shin, M.D. PhD.         
Kyungpook National University Chilgok Hospital Recruiting
Daegu, Korea, Republic of
Contact: Yee Soo Chae, M.D. PhD.         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sung-Bae Kim, M.D. PhD.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Myung-Ju Ahn, M.D. PhD.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Bum-Suk Keam, M.D. PhD.         
Sponsors and Collaborators
ISU Abxis Co., Ltd.
Investigators
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Study Director: Jaehyeon Juhn, Ph.D ISU Abxis Co., Ltd.

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Responsible Party: ISU Abxis Co., Ltd.
ClinicalTrials.gov Identifier: NCT03552406     History of Changes
Other Study ID Numbers: ISU104-001
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ISU Abxis Co., Ltd.:
Solid tumor
Breast cancer
Head & Neck cancer
Additional relevant MeSH terms:
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Neoplasms
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs