A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers (NCT03448042) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
United States123 participantsStarted 2018-06-06
Plain-language 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 advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.
Who can participate
Age range18 Years
SexALL
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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 inappropria…
What they're measuring
1
Percentage of Participants with Adverse Events
Timeframe: From baseline through end of study (approximately 78 months)