A Study of the Safety and Pharmacokinetics (PK) of MEHD7945A in Participants With Locally Advanced or Metastatic Epithelial Tumors
Epithelial Tumors, Malignant
About this trial
This is an interventional treatment trial for Epithelial Tumors, Malignant
Eligibility Criteria
Inclusion Criteria:
- Life expectancy greater than or equal to (>/=) 12 weeks
- Availability and willingness to provide sufficient tumor tissue sample for testing
- Dose-escalation stage: Participants with histologically documented incurable, locally advanced, or metastatic epithelial malignancy that has progressed despite standard therapy or for which no standard therapy exists
- Expansion stage: Participants with one of the following epithelial, histologically-documented, incurable, locally advanced, or metastatic tumor that has progressed despite standard therapy or for which no standard therapy exists: CRC, NSCLC, HNSCC, or pancreatic cancer
- Use of an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for men and women of childbearing potential while enrolled in the study
Exclusion Criteria:
- Less than (<) 4 weeks since the last anti-tumor therapy prior to Day 1 of study treatment
- Major surgical procedure within 4 weeks prior to Cycle 1, Day 1
- Leptomeningeal disease as the only manifestation of the current malignancy
- Active infection requiring IV antibiotics
- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
- Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- Current severe, uncontrolled systemic disease
- History of cardiac heart failure of any New York Heart Association criteria or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction within 6 months before Cycle 1, Day 1, or history of unstable angina
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- History of interstitial lung disease
- History of severe allergic or hypersensitivity reaction to other therapeutic antibodies that required discontinuation of therapy
- Known human immunodeficiency virus (HIV) infection
- Primary central nervous system (CNS) malignancy or untreated/active CNS metastases
- Significant traumatic injury within 4 weeks before Cycle 1, Day 1
- Pregnancy or lactation
Sites / Locations
- Uni of Colorado Cancer Center; Anschutz Cancer Pavilion
- Massachusetts General Hospital.
- University of Texas M.D. Anderson Cancer Center
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
- HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
- Hospital Clinico Universitario de Valencia
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Dose Escalation (MEHD7945A)
Dose Expansion (MEHD7945A)
Participants will receive intravenous (IV) infusion of MEHD7945A in escalating doses Q2W until MTD is reached or up to disease progression as determined by the investigator, intolerable toxicity, withdrawal of consent, or death, whichever occurs first. Approximately 5 dose levels between 1 and 30 mg/kg will be evaluated.
Participants will receive IV infusion of MEHD7945A Q2W at or below the MTD (decided from dose escalation part) up to disease progression as determined by the investigator, intolerable toxicity, withdrawal of consent, or death, whichever occurs first.