Status:
ACTIVE_NOT_RECRUITING
A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
Lead Sponsor:
Genentech, Inc.
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally adv...
Eligibility Criteria
Inclusion
- 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 \</=1 prior to study entry
- Left Ventricular Ejection Fraction (LVEF) \>/=50%
- HER2-Expressing Breast Cancer-Specific Inclusion Criteria
- 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
- HER2-Expressing Gastric/Gastroesophageal (GEJ) Cancer-Specific Inclusion Criteria
- 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 Solid Tumor Specific Inclusion Criteria
- 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
- 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
- Known clinically significant liver disease
- 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
Exclusion
Key Trial Info
Start Date :
June 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2026
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT03448042
Start Date
June 6 2018
End Date
May 30 2026
Last Update
December 1 2025
Active Locations (27)
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1
Yale University
New Haven, Connecticut, United States, 06511
2
Washington University
Saint Louis, Michigan, United States, 63130
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10017
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203