Clinical trial · Interventional
A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC
An Open-Label, Single-arm, Phase I Study to Evaluate the Pharmacokinetics, Tolerability and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, Single-arm, Phase I clinical study to evaluate the pharmacokinetics, tolerability and safety of margetuximab plus chemotherapy in Chinese patients with advanced HER2+ breast cancer who have received standard anti-HER2 directed therapy in the metastatic setting (mandatory including trastuzumab). The primary endpoint of this study is PK parameters of margetuximab.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Positive Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Margetuximab Margetuximab-IV | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Margetuximab & Chosen Chemotherapy
- description
- The dosage and administering of margetuximab is 15 mg/kg IV every 21 days. Investigators need to choose one of the 3 chemotherapies based on patient conditions.
- interventionNames
- Drug: Margetuximab Margetuximab-IV
Primary outcomes (4)
- measure
- Evaluation of pharmacokinetic parameter of margetuximab Cmax
- timeFrame
- Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
- measure
- Evaluation of pharmacokinetic parameter of margetuximab Tmax
- timeFrame
- Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent obtained prior to performing any protocol-related procedures * Male or female, age ≥ 18 years old at the time of screening. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Subject has histologically confirmed HER2 positive metastatic breast cancer. * Have received standard anti-HER2 directed therapy in the metastatic setting (mandatory to have trastuzumab), regardless of having received (neo)adjuvant anti-HER2 therapy or not. * Have received treatment with no more than four lines of therapy overall in the metastatic setting (including anti-HER2 targeted therapy or chemotherapy) and must have disease progressed on or after, the most recent line of therapy. per RECIST 1.1. * Previous adverse events associated with anti-tumor therapy have been recovered to NCI-CTCAE v4.03 Grade ≤1 (except NCI-CTCAE v4.03 Grade ≤2 alopecia, stable sensory neuropathy, or stabilized electrolyte disturbance after fluid transfusion). * Subject has life expectancy ≥12 weeks. * Subject has no supportive therapy of blood transfusion or growth factor within 4 weeks before dosed and has adequate organ functions * Subject has a negative test result of pregnancy test at screening. Exclusion Criteria: * Subject has symptomatic, uncontrolled brain or pia mater metastasis. * Subject has third interstitial effusion that cannot be controlled by drainage or other means. * Subject has local or systemic anti-tumor treatment within 2 weeks prior to enrollment * Subject has any investigational treatment within 4 weeks prior to enrollment (including margetuximab) * Subject has history of major surgery with unrecovered surgical effect within 4 weeks prior to enrollment * Subject has other malignant tumor (complete cured in situ cervical cancer, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma are not included) within 5 years prior to enrollment * Subject has severe and uncontrolled disease
References
Publications (0)
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