HER2-expressing cancer (Currently breast cancer and gastric/GEJ cancer only)
Conditions
Interventions
Runimotamab is administered via IV in escalating doses
Sponsors
Iris Chan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 -Life expectancy of at least 12 weeks -Adequate hematologic and end-organ function -Acute, clinically significant treatment-related toxicity from prior therapy must have resolved to Grade /=50% -Locally tested, Human Epidermal Growth Factor Receptor 2 (HER2)-expressing BC -Locally advanced or metastatic BC that has relapsed or is refractory to established therapies -Adenocarcinoma of the stomach or GEJ with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy -HER2-expressing tumor (primary tumor or metastasis) as assessed by local lab testing -HER2-positive gastric/GEJ cancer must have received prior trastuzumab, cisplatin (or carboplatin or oxaliplatin or investigational platinum agent) and 5-fluorouracil (5-FU)/capecitabine -HER2-positive tumor (primary tumor or metastasis) as assessed by local (non-central) laboratory testing -Locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care; or for whom a clinical trial of an investigational agent is considered an acceptable treatment option
Exclusion criteria
Exclusion criteria: -Pregnant or breastfeeding, or intending to become pregnant during the study or within 140 days after the last dose of runimotamab -Significant cardiopulmonary dysfunction -Known clinically significant liver disease -Positive for acute or chronic Hepatitis B virus (HBV) infection -Acute or chronic Hepatitis C virus (HCV) infection -Human Immunodeficiency Virus (HIV) seropositivity -Poorly controlled Type 2 diabetes mellitus -History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias -Current treatment with medications that are well known to prolong the Q-wave/T-wave (QT) interval -Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control) -Leptomeningeal disease -Spinal cord compression that has not definitively treated with surgery and/or radiation -History of autoimmune disease -Prior allogeneic stem cell or solid organ transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Occurrence and nature of DLTs Occurrence, nature, and severity of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, Phamacokinetics 1. Serum Concentration 2. AUC 3. Cmax 4. Cmin 5. CL 6. Vss 7. OR 8. DOR 9. ADA | — |
Countries
Australia, Belgium, Canada, Denmark, France, Italy, Japan, Korea, Netherlands, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed