A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants With Locally Advanced or Metastatic Solid Tumors
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/28/2019 |
Start Date: | August 12, 2014 |
End Date: | December 3, 2019 |
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
13
sites
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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