A PHASE Ia/b, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF RUNIMOTAMAB ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT AND IN COMBINATION WITH TRASTUZUAMB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HER2-EXPRESSING CANCERS - GO40311

Genentech Inc.0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•General inclusion criteria:
•* ECOG Performance Status of 0 or 1
•* Life expectancy of at least 12 weeks
•* Adequate hematologic and end-organ function
•* LVEF equal to or over 50% by either ECHO or MUGA scan
•* All acute, clinically significant treatment-related toxicity from prior
•therapy, except for alopecia and G2 anemia (Hb 9.0 g/dL), must have resolved to
•grade equal to or under 1 prior to study entry
•HER2-Positive Breast Cancer-Specific Inclusion Criteria:
•* Locally tested, HER2 BC
•* Locally advanced or metastatic BC that has relapsed or is refractory to
•established therapies
•HER2-Positive gastric/gej cancer-specific inclusion criteria:
•* Histologically or cytologically documented adenocarcinoma of the stomach or
•GEJ with inoperable locally advanced or recurrent and/or metastatic disease,
•not amenable to curative therapy.
•* HER2 tumor (primary tumor or metastasis) as assessed by local (non-central)
•laboratory testing
•* Must have received prior trastuzumab, cisplatin (or carboplatin or
•oxaliplatin or investigational platinum agent) and 5-FU/capecitabine
•For more specific inclusion criteria, please refer to p.104-106 of the protocol

•Patients who meet any of the following criteria will be excluded from study
•entry. Unless specified, all exclusion criteria listed apply to both the Phase
•* Pregnant or breastfeeding, or intending to become pregnant during the study
•or within 140 days after the last dose of Runimotamab or tocilizumab, and
•within 7 months after the last dose of trastuzumab (for the Phase Ib).
•* Significant cardiopulmonary dysfunction
•* Known clinically significant liver disease
•* Positive serologic or PCR test results for acute or chronic HBV infection
•* Acute or chronic HCV infection
•* 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 QT
•* Primary 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
•* History of autoimmune disease
•* Prior allogeneic stem cell or solid organ transplantation

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