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Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients

Primary Purpose

HER2-positive Breast Cancer

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ALT-P7 (HM2-MMAE)
Sponsored by
Alteogen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HER2-positive Breast Cancer focused on measuring HER2 Positive Breast Cancer, ALT-P7, Antibody-Drug Conjugate

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient who voluntarily signed the agreement
  2. Adult patients ≥ 19 years of age
  3. Eastern Cooperative Oncology Group(ECOG) Performance status of 0 or 1
  4. Appropriate organism function proven by the following laboratory test results

    • Absolute neutrophil count ≥ 1500 cells/mm³
    • Platelets ≥ 100,000 cells/mm³
    • Hemoglobin ≥ 9.0 g/dL

      • Patients can receive red blood cell transfusions at this level.
    • Creatinine ≤ 1.5 × Upper Limit of Normal(ULN)
    • Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤ 2.5 × ULN
    • Alkaline phosphatase ≤ 2.5 × ULN

      • Patients with liver and/or bone metastases: AST and ALT ≤ 5 × ULN, Alkaline phosphatase ≤ 5 × ULN
    • Albumin ≥ 3.0 g/dL, Total bilirubin ≤ 2.0 mg/dL
    • International Normalized Ratio(INR) < 1.5 × ULN(Except when you are on therapeutic anticoagulation therapy)
  5. It should be negative in serum pregnancy test in the case of pre-menopausal women and women who were menopausal for less than 12 months
  6. In the case of a fertile woman, it should be negative in pregnancy test, and all men and women should use effective contraceptive methods while enrolled in this study. You must also agree to continue the contraception during the trial and up to 6 months after the last dose of the test
  7. Those who are expected to understand and observe the clinical trial plan according to the tester's judgment
  8. Those who voluntarily agreed to participate in this clinical trial and signed the agreement

Exclusion Criteria:

  • Criteria for disease

    1. Previous history of intolerance to Trastuzumab including Grade 3-4 infusion reaction or hypersensitivity
    2. Previous history of permanent discontinuation of Trastuzumab due to the toxicity
    3. A person who has untreated or symptomatic brain metastasis, or brain metastasis requiring radiation, surgery or corticosteroid therapy to control the brain metastases within 4 weeks of the first administration
    4. Current Grade ≥ 2 (according to National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) v4.03 of peripheral neuropathy
    5. If the toxicity of the previous treatment is not recovered to baseline level or lower than Grade 1 except for hair loss and peripheral neuropathy
    6. Hypercalcemia requiring bisphosphonate therapy (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN) However, it is allowed if bisphosphonate has been used for bone metastasis
    7. A person who has received clinical trial material, chemotherapy, hormone therapy, radiotherapy, immunotherapy or biological therapy within 3 weeks of the first administration. However, it is required a minimum of 2 weeks after surgery if stereotactic radiosurgery is performed
    8. Previous history of exposure to the cumulative dose of anthracycline (Doxorubicin > 360 mg/m², Epirubicin > 600 mg/m²)
  • Criteria for cardio pulmonary function

    1. Unstable ventricular arrhythmia requiring treatment
    2. Previous history of symptomatic congestive heart failure (NYHA Class II-IV)
    3. Previous history of myocardial infarction or unstable angina within 6 months
    4. Cardiac troponin I ≥ 0.2 ng/mL
    5. A person who has inadequate left ventricular ejection fraction(LVEF) within 3 weeks of the first administration, LVEF <50% by echocardiography or Multiple-gated Acquisition(MUGA)
    6. A person who has severe dyspnea or pneumonia requiring continuous oxygen therapy
  • Common criteria

    1. Pregnant or breastfeeding
    2. A person who has undergone surgical operation or significant traumatic injury within 30 days before registration, or is expected to require surgical operation during the clinical trial
    3. Previous history of malignant tumors other than breast cancer within 5 years prior to screening (patient who can participate: squamous cell and basal cell carcinoma of the skin, intraepithelial cancer of the cervix, thyroid papillary cancer, or if the tester considers that the risk of relapse is minimum(regard as full recovery) and the sponsor agrees with it)
    4. A person who needs chronic corticosteroid therapy (≥ 10 mg/day prednisone or equivalent volume of other anti-inflammatory corticosteroids)
    5. If the result of human immunodeficiency virus (HIV), active hepatitis B or hepatitis C is positive during screening
    6. Patients with uncontrolled concomitant illnesses, including mental illness/social conditions, which may affect compliance with clinical trial procedures

Sites / Locations

  • Alteogen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALT-P7

Arm Description

8 groups: 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.2 mg/kg, 4.5 mg/kg, 4.8 mg/kg, Administration: Day 1 of each 3-week cycle

Outcomes

Primary Outcome Measures

DLT test
Determination of Maximum Tolerated Dose(MTD) and the dose level showing Dose Limiting Toxicity(DLT), or determination of Recommended Phase II Dose(RP2D) as an alternative to MTD establishment

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
Evaluate adverse events by the Common Terminology Criteria for Adverse Event (CTCAE v4.03) classification, immune-related adverse events(irAEs)
Pharmacokinetics test
analyze metabolism and discover the fate of a ALT-P7 from administration up to completely eliminated from the body (Group 3(1.2 mg/kg) ~ Group 7(5.4 mg/kg))
Immunogenicity test
After administration of the drug for clinical trial, the descriptive statistics of the dose group and the measurement point are calculated
Efficacy test
Provide descriptive statistics for each capacity group(the number of subjects, average, standard deviation, median, minimum value, maximum value)

Full Information

First Posted
September 5, 2017
Last Updated
January 14, 2022
Sponsor
Alteogen, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03281824
Brief Title
Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients
Official Title
Open-Label, Dose Increase and Phase I Study of ALT-P7 to Determine Safety, Tolerability, Pharmacokinetics for HER2 Positive Metastatic Breast Cancer Patients Who Have Progressed on Previous Trastuzumab-Based Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alteogen, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This open-label study assessed the safety, tolerability and pharmacokinetics of ALT-P7(HM2-Drug Conjugate) in patients with HER2-positive metastatic breast cancer who have progressed on previous Trastuzumab-based therapy. Patients received ALT-P7(0.3 mg/kg~5.4 mg/kg, 7 groups) intravenously on Day 1 of each 3-week cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer
Keywords
HER2 Positive Breast Cancer, ALT-P7, Antibody-Drug Conjugate

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALT-P7
Arm Type
Experimental
Arm Description
8 groups: 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.2 mg/kg, 4.5 mg/kg, 4.8 mg/kg, Administration: Day 1 of each 3-week cycle
Intervention Type
Biological
Intervention Name(s)
ALT-P7 (HM2-MMAE)
Intervention Description
Antibody-Drug Conjugate
Primary Outcome Measure Information:
Title
DLT test
Description
Determination of Maximum Tolerated Dose(MTD) and the dose level showing Dose Limiting Toxicity(DLT), or determination of Recommended Phase II Dose(RP2D) as an alternative to MTD establishment
Time Frame
21 days after first administration
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Evaluate adverse events by the Common Terminology Criteria for Adverse Event (CTCAE v4.03) classification, immune-related adverse events(irAEs)
Time Frame
up to 4 weeks
Title
Pharmacokinetics test
Description
analyze metabolism and discover the fate of a ALT-P7 from administration up to completely eliminated from the body (Group 3(1.2 mg/kg) ~ Group 7(5.4 mg/kg))
Time Frame
up to 4 weeks
Title
Immunogenicity test
Description
After administration of the drug for clinical trial, the descriptive statistics of the dose group and the measurement point are calculated
Time Frame
up to 4 weeks
Title
Efficacy test
Description
Provide descriptive statistics for each capacity group(the number of subjects, average, standard deviation, median, minimum value, maximum value)
Time Frame
At the end of Cycle 2 (each cycle is 21 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient who voluntarily signed the agreement Adult patients ≥ 19 years of age Eastern Cooperative Oncology Group(ECOG) Performance status of 0 or 1 Appropriate organism function proven by the following laboratory test results Absolute neutrophil count ≥ 1500 cells/mm³ Platelets ≥ 100,000 cells/mm³ Hemoglobin ≥ 9.0 g/dL Patients can receive red blood cell transfusions at this level. Creatinine ≤ 1.5 × Upper Limit of Normal(ULN) Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤ 2.5 × ULN Alkaline phosphatase ≤ 2.5 × ULN Patients with liver and/or bone metastases: AST and ALT ≤ 5 × ULN, Alkaline phosphatase ≤ 5 × ULN Albumin ≥ 3.0 g/dL, Total bilirubin ≤ 2.0 mg/dL International Normalized Ratio(INR) < 1.5 × ULN(Except when you are on therapeutic anticoagulation therapy) It should be negative in serum pregnancy test in the case of pre-menopausal women and women who were menopausal for less than 12 months In the case of a fertile woman, it should be negative in pregnancy test, and all men and women should use effective contraceptive methods while enrolled in this study. You must also agree to continue the contraception during the trial and up to 6 months after the last dose of the test Those who are expected to understand and observe the clinical trial plan according to the tester's judgment Those who voluntarily agreed to participate in this clinical trial and signed the agreement Exclusion Criteria: Criteria for disease Previous history of intolerance to Trastuzumab including Grade 3-4 infusion reaction or hypersensitivity Previous history of permanent discontinuation of Trastuzumab due to the toxicity A person who has untreated or symptomatic brain metastasis, or brain metastasis requiring radiation, surgery or corticosteroid therapy to control the brain metastases within 4 weeks of the first administration Current Grade ≥ 2 (according to National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) v4.03 of peripheral neuropathy If the toxicity of the previous treatment is not recovered to baseline level or lower than Grade 1 except for hair loss and peripheral neuropathy Hypercalcemia requiring bisphosphonate therapy (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN) However, it is allowed if bisphosphonate has been used for bone metastasis A person who has received clinical trial material, chemotherapy, hormone therapy, radiotherapy, immunotherapy or biological therapy within 3 weeks of the first administration. However, it is required a minimum of 2 weeks after surgery if stereotactic radiosurgery is performed Previous history of exposure to the cumulative dose of anthracycline (Doxorubicin > 360 mg/m², Epirubicin > 600 mg/m²) Criteria for cardio pulmonary function Unstable ventricular arrhythmia requiring treatment Previous history of symptomatic congestive heart failure (NYHA Class II-IV) Previous history of myocardial infarction or unstable angina within 6 months Cardiac troponin I ≥ 0.2 ng/mL A person who has inadequate left ventricular ejection fraction(LVEF) within 3 weeks of the first administration, LVEF <50% by echocardiography or Multiple-gated Acquisition(MUGA) A person who has severe dyspnea or pneumonia requiring continuous oxygen therapy Common criteria Pregnant or breastfeeding A person who has undergone surgical operation or significant traumatic injury within 30 days before registration, or is expected to require surgical operation during the clinical trial Previous history of malignant tumors other than breast cancer within 5 years prior to screening (patient who can participate: squamous cell and basal cell carcinoma of the skin, intraepithelial cancer of the cervix, thyroid papillary cancer, or if the tester considers that the risk of relapse is minimum(regard as full recovery) and the sponsor agrees with it) A person who needs chronic corticosteroid therapy (≥ 10 mg/day prednisone or equivalent volume of other anti-inflammatory corticosteroids) If the result of human immunodeficiency virus (HIV), active hepatitis B or hepatitis C is positive during screening Patients with uncontrolled concomitant illnesses, including mental illness/social conditions, which may affect compliance with clinical trial procedures
Facility Information:
Facility Name
Alteogen
City
Daejeon
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients

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