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

NCT ID: NCT02219724

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-12
• Study Completion Date: 2019-08-18

Brief 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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MOXR0916: Dose Escalation Stage

Participants in different cohorts (according to MOXR0916 dose received) will receive escalating doses of MOXR0916 to determine the MTD or maximum administered dose (MAD) for 21 to 42 days.

Group Type: EXPERIMENTAL

MOXR0916

Intervention Type: DRUG

MOXR0916 will be administered as intravenous infusion on Day 1 of each 21-day cycle.

MOXR0916: Expansion Stage

Participants in different cohorts (according to different cancer types, prior therapy and mandatory procedures on study) will receive MOXR0916 at the highest dose level that has already been deemed to be tolerable in the dose escalation stage until disease progression, loss of clinical benefit or unacceptable toxicity, whichever occurred first (approximately up to 3 years).

Group Type: EXPERIMENTAL

MOXR0916

Intervention Type: DRUG

MOXR0916 will be administered as intravenous infusion on Day 1 of each 21-day cycle.

Interventions

MOXR0916

MOXR0916 will be administered as intravenous infusion on Day 1 of each 21-day cycle.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

Asan Medical Center - Oncology

Seoul, , South Korea

Yonsei University Health System/Severance Hospital

Seoul, , South Korea

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hosp de Madrid Norte Sanchinarro; Centro Integral; Onco Clara Campal

Madrid, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Countries

United States; Australia; Belgium; Canada; South Korea; Spain

Other Identifiers

2014-001474-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO29313

Identifier Type: -

Identifier Source: org_study_id