A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants With Locally Advanced or Metastatic Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasms

In brief

This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered intravenously in participants with locally advanced or metastatic solid tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate. This study will consist of a screening period, an initial treatment period, a re-treatment period (for participants who discontinue MOXR0916 after demonstration of prolonged clinical benefit), and a post-treatment follow-up period. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage. The planned duration of the study is approximately 3 years.

Key facts

Study ID

NCT02219724

Run by

Genentech, Inc.

People needed

174

Starts

2014-08-12

Expected to finish

2019-08-18

Last updated by the study team

2020-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic documentation of locally advanced, recurrent or metastatic incurable solid malignancy that has progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate
• Confirmed availability of representative tumor specimens in paraffin blocks/unstained slides
• Measurable disease per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematologic and end organ function
• For female participants of childbearing potential, agreement to use highly effective form(s) of contraception and to continue its use for 6 months after the last dose of MOXR0916

You may not qualify if…

• Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment (hormonal therapy with gonadotropin-releasing hormone agonists or antagonists for prostate cancer and palliative radiotherapy greater than (>) 2 weeks prior to Cycle 1, Day 1 are allowed)
• Eligibility based on prior treatment with immunomodulatory agents depends on the mechanistic class of the drug and the cohort for which the participant is being considered
• Adverse events from prior anti-cancer therapy that have not resolved to Grade less than or equal to (</=) 1 except for alopecia or endocrinopathy managed with replacement therapy
• Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
• Leptomeningeal disease
• Malignancies other than disease under study within 5 years
• History of autoimmune disease
• History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
• Positive test for human immunodeficiency virus infection
• Active hepatitis B or active hepatitis C
• Severe infections within 4 weeks or signs or symptoms of infection within 2 weeks prior to Cycle 1
• Prior allogeneic bone marrow transplantation or prior solid organ transplantation
• Significant cardiovascular disease
• Known clinically significant liver disease

Where it is running

• HonorHealth Research Institute - Bisgrove — Scottsdale, Arizona, United States
• University of Colorado — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Georgetown University Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• University Of Chicago Medical Center; Section Of Hematology/Oncology — Chicago, Illinois, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Can Ins — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
• Austin Hospital — Heidelberg, Victoria, Australia
• Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
• Institut Jules Bordet — Brussels, Belgium
• UZ Gent — Ghent, Belgium
• Sint Augustinus Wilrijk — Wilrijk, Belgium
• British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre — Vancouver, British Columbia, Canada
• Hamilton Health Sciences - Juravinski Cancer Centre — Hamilton, Ontario, Canada
• The Ottawa Hospital Cancer Centre; Oncology — Ottawa, Ontario, Canada
• University Health Network; Princess Margaret Hospital; Medical Oncology Dept — Toronto, Ontario, Canada
• McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology — Montreal, Quebec, Canada
• Seoul National University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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