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

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ClinicalTrials.gov Identifier: NCT03281824
Recruitment Status : Active, not recruiting
First Posted : September 13, 2017
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Alteogen, Inc.

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 13, 2017
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE January 11, 2018
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
DLT test [ Time Frame: 21 days after first administration ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: up to 4 weeks ]
    Evaluate adverse events by the Common Terminology Criteria for Adverse Event (CTCAE v4.03) classification, immune-related adverse events(irAEs)
  • Pharmacokinetics test [ Time Frame: up to 4 weeks ]
    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 [ Time Frame: up to 4 weeks ]
    After administration of the drug for clinical trial, the descriptive statistics of the dose group and the measurement point are calculated
  • Efficacy test [ Time Frame: At the end of Cycle 2 (each cycle is 21 days) ]
    Provide descriptive statistics for each capacity group(the number of subjects, average, standard deviation, median, minimum value, maximum value)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: up to 4 weeks ]
    Evaluate adverse events by the Common Terminology Criteria for Adverse Event (CTCAE v4.03) classification, irAEs
  • PK test [ Time Frame: up to 4 weeks ]
    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 [ Time Frame: up to 4 weeks ]
    After administration of the drug for clinical trial, the descriptive statistics of the dose group and the measurement point are calculated
  • Efficacy test [ Time Frame: At the end of Cycle 2 (each cycle is 21 days) ]
    Provide descriptive statistics for each capacity group(the number of subjects, average, standard deviation, median, minimum value, maximum value)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE HER2-positive Breast Cancer
Intervention  ICMJE Biological: ALT-P7 (HM2-MMAE)
Antibody-Drug Conjugate
Study Arms  ICMJE Experimental: ALT-P7
  • 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: Biological: ALT-P7 (HM2-MMAE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03281824
Other Study ID Numbers  ICMJE ALT-P7
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alteogen, Inc.
Study Sponsor  ICMJE Alteogen, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alteogen, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP