A study to look at how safe different doses of the study medicine (MOXR0916) were for patients with solid tumor cancer that had spread and did not respond to previous treatment(s), and how this medicine was processed by the body

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

Cancer
Tumor
Neoplasms
Solid Tumors

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Basic Details

Gender

All

Age

≥18 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT02219724, GO29313, 2014-001474-34

MOXR0916 is a new medicine (immunotherapy) designed to work on the immune system. Researchers wanted to find out what dose of MOXR0916 was safe to give to cancer patients and what effects, good and/or bad, it had on patients and on their cancers. This was the first time MOXR0916 was given to humans.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Trial Identifier NCT02219724, GO29313, 2014-001474-34

Condition Neoplasms

Official Title 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

Study Summary

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.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

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

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study to look at how safe different doses of the study medicine (MOXR0916) were for patients with solid tumor cancer that had spread and did not respond to previous treatment(s), and how this medicine was processed by the body

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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Find participating medical centers and current study status in each of them

A study to look at how safe different doses of the study medicine (MOXR0916) were for patients with solid tumor cancer that had spread and did not respond to previous treatment(s), and how this medicine was processed by the body

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com