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

NCT03281824 | Completed Phase 1

• 1 other identifier: ALT-P7
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Breast Cancer

Keywords

HER2 Positive Breast Cancer; ALT-P7; Antibody-Drug Conjugate

Outcome Measures

Primary Outcomes (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

  21 days after first administration

Secondary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events

  up to 4 weeks

• Pharmacokinetics test

  up to 4 weeks

• Immunogenicity test

  up to 4 weeks

• Efficacy test

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

Study Arms (1)

ALT-P7

EXPERIMENTAL

* 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

Biological: ALT-P7 (HM2-MMAE)

Interventions

ALT-P7 (HM2-MMAE) BIOLOGICAL

Antibody-Drug Conjugate

ALT-P7

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alteogen, Inc.: lead

Study Sites (1)

Alteogen

Daejeon, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 13, 2017
• Study Start: January 11, 2018
• Primary Completion: March 12, 2020
• Study Completion: January 15, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

KR (1)