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HER2-positive Breast CancerPhase 1NCT03281824

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

A Phase 1 study testing ALT-P7 (HM2-MMAE) in people with HER2-positive Breast Cancer, run by Alteogen, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
ALT-P7 (HM2-MMAE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteSouth Korea
Study dates
11 Jan 2018to 15 Jan 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Alteogen

    Daejeon

Other trials in South Korea

About this study

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

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.

Being tested
ALT-P7 (HM2-MMAE)
Keywords
HER2 Positive Breast Cancer, ALT-P7, Antibody-Drug Conjugate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALT-P7 (HM2-MMAE)Biological

    Antibody-Drug Conjugate

Study groups in NCT03281824
Study groupRoleWhat they receive
ALT-P7Experimental* 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
Receives: Biological: ALT-P7 (HM2-MMAE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 21 days after first administration

Secondary outcomes (4)

  1. 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)

    Measured: up to 4 weeks

  2. 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))

    Measured: up to 4 weeks

  3. Immunogenicity test

    After administration of the drug for clinical trial, the descriptive statistics of the dose group and the measurement point are calculated

    Measured: up to 4 weeks

  4. Efficacy test

    Provide descriptive statistics for each capacity group(the number of subjects, average, standard deviation, median, minimum value, maximum value)

    Measured: At the end of Cycle 2 (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2017
  2. Study start11 Jan 2018
  3. Primary completion12 Mar 2020
  4. Study completion15 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03281824
Sponsor's protocol ID
ALT-P7
Status last verified
Jan 2022
First submitted
5 Sep 2017
Last updated
18 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALT-P7 (HM2-MMAE) in people with HER2-positive Breast Cancer, run by Alteogen, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT test (time frame: 21 days after first administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03281824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.

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