Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This trial involves a dose escalation and expansion phase. In the dose escalation phase, patients will be assigned sequentially to escalating doses of BTRC4017A, up to the maximum tolerated dose (MTD). In the dose expansion phase, patients will receive receive BTRC4017A based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
Conditions
This trial is treating people with HER2-expressing cancers
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Genentech
Scientific Title
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of BTRC4017A Administered Intravenously in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers
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