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

NCT02219724 | Completed Phase 1

• 2 other identifiers: GO293132014-001474-34
• Study Type: interventional
• Target: 174
• Locations: 6 countries
• Sites: 31

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Dose Limiting Toxicities (DLTs)

  Day 1 Up to Day 21 or 42

• Percentage of Participants With Adverse Events (AEs) by Severity as Graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)

  Baseline up to 90 days after the last dose of study treatment, or until the initiation of another systemic anti-cancer therapy, whichever occurs first (approximately up to 3 years)

Secondary Outcomes (17)

• Maximum Tolerated Dose (MTD) of MOXR0916

  Baseline up to 21 to 42 days

• Recommended Phase II Dose of MOXR0916

  Baseline up to 21 to 42 days

• Percentage of Participants With Anti-MOXR0916 Antibodies

  Pre-dose (Hour [Hr] 0) on Day (D) 1 of Cycles (Cy) 1,2,3,4,8,12,16, & then every 8 Cy up to treatment discontinuation visit (TDV) (up to approximately 3 years) (1 Cy=21 days), thereafter every 30 days for up to 120 days after treatment discontinuation

• Number of Cycles of MOXR0916 Treatment Received

  Baseline up to approximately 3 years

• Mean MOXR0916 Dose Administered During Study

  Baseline up to approximately 3 years

Study Arms (2)

MOXR0916: Dose Escalation Stage

EXPERIMENTAL

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.

Drug: MOXR0916

MOXR0916: Expansion Stage

EXPERIMENTAL

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).

Drug: MOXR0916

Interventions

MOXR0916 DRUG

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

MOXR0916: Dose Escalation Stage; MOXR0916: Expansion Stage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (31)

HonorHealth Research Institute - Bisgrove

Scottsdale, Arizona, 85258, United States

Location

University of Colorado

Aurora, Colorado, 80045-2517, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

University Of Chicago Medical Center; Section Of Hematology/Oncology

Chicago, Illinois, 60637, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Can Ins

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Peter Maccallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Sint Augustinus Wilrijk

Wilrijk, 2610, Belgium

Location

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

The Ottawa Hospital Cancer Centre; Oncology

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network; Princess Margaret Hospital; Medical Oncology Dept

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Montreal, Quebec, H3T 1E2, Canada

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center - Oncology

Seoul, 05505, South Korea

Location

Yonsei University Health System/Severance Hospital

Seoul, 120-752, South Korea

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

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

Madrid, 28050, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 19, 2014
• Study Start: August 12, 2014
• Primary Completion: July 14, 2017
• Study Completion: August 18, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

AU (4); CA (5); KR (3); US (12); ES (4); BE (3)