MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:August 31, 2015
End Date:July 1, 2019
Contact:US Medical Information
Phone:888-275-7376

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A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability,Pharmacokinetics, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose
levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means
the study drug has not previously been given to humans or has only been given to a limited
number of people, although it has been extensively studied in animals. Based on this
information, it is hoped to find out which dose could be best for the treatment of patients.
There are two parts of this research study: a dose-escalation part and an expansion part.
Dose escalation means that the first people taking part in the study will receive low doses
of the study drug, and as more people take part, the additional participants will receive a
higher dose. This is done to find the safest dose for the study drug. Expansion means that
after the dose-escalation part of the study has looked at the safety and effectiveness of
different doses, many more people will be invited to take part in the study and will receive
the study drug at the safest dose. Additional purposes of the study are to find out whether
the study drug has anti-cancer effects and how the study drug is processed by the body.

This is a Phase I, open-label, dose-escalation trial with consecutive parallel-group
expansion in selected solid tumor indications. The current trial is composed of a standard
dose escalation "3 + 3" cohort design, for which 3 to 6 subjects will be enrolled at each
dose level depending on the occurrence of dose limiting toxicities (DLTs), followed by a
consecutive parallel-group expansion in selected solid tumor indications. Cohorts of 3
subjects with metastatic or locally advanced solid tumors, for which no standard effective
therapy exists or standard therapy has failed, will receive MSB0011359C (M7824) at escalating
dose levels. After determination of the Maximum tolerated dose (MTD), enrollment in several
expansion cohorts will be opened to determine the safety, pharmacokinetic (PK) /
Pharmacodynamic, and clinical activity of MSB0011359C (M7824). Subjects who have experienced
a confirmed complete response (CR) should continue treatment through the end of 12 months,
although additional treatment is possible. In the case of progressive disease (PD), subjects
should continue treatment through their next tumor assessment. Additional indications will be
planned based on emerging data in the field.

Inclusion Criteria:

- Ability to understand the purpose of the study, provide signed and dated informed
consent, and able to comply with all procedures

- Male or female subjects aged greater than or equal to (>=) 18 years

- Life expectancy >= 12 weeks as judged by the Investigator

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry

- Disease must be measurable with at least 1 uni dimensional measurable lesion by
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

- Adequate hematological, hepatic and renal function as defined in the protocol

- Effective contraception for both male and female subjects if the risk of conception
exists

Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

- Concurrent treatment with non-permitted drugs and other interventions

- Anticancer treatment within 28 days before the start of trial treatment, for example
cyto reductive therapy, radiotherapy (with the exception of palliative radiotherapy
delivered in a normal organ-spearing technique), immune therapy, or cytokine therapy

- Major surgery within 28 days before the start of trial treatment (prior diagnostic
biopsy is permitted)

- Systemic therapy with immunosuppressive agents within 7 days before the start of trial
treatment; or use of any investigational drug within 28 days before the start of trial
treatment

- Previous malignant disease (other than the target malignancy to be investigated in
this trial) within the last 3 years. Subjects with history of cervical carcinoma in
situ, superficial or non invasive bladder cancer or basal cell or squamous cell cancer
in situ previously treated with curative intent are NOT excluded. Subjects with other
localized malignancies treated with curative intent need to be discussed with the
Medical Monitor.

- Rapidly progressive disease which, in the opinion of the Investigator, may predispose
to inability to tolerate treatment or trial procedures

- Subjects with active central nervous system (CNS) metastases causing clinical symptoms
or metastases that require therapeutic intervention are excluded

- Receipt of any organ transplantation, including allogeneic stem-cell transplantation,
but with the exception of transplants that do not require immunosuppression (eg,
corneal transplant, hair transplant)

Other protocol-defined exclusion criteria could apply
We found this trial at
49
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Atlanta, Georgia 30322
Principal Investigator: Donald Harvey
Phone: 404-778-5849
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Michael Lee
Phone: 919-966-4432
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Principal Investigator: Michael Wertheim
Phone: 772-408-5164
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Howard Safran
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Rodolfo Bordoni
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Austin, Texas 78705
Principal Investigator: Jason Melear
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Bethesda, Maryland
Principal Investigator: James Gulley
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Principal Investigator: Ralph Boccia
Phone: 240-482-0523
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Bethesda, Maryland 20817
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18 Blacktown Road
Blacktown, New South Wales 2148
Principal Investigator: Mark Wong
Phone: +61286705070
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Boca Raton, Florida 33486
Principal Investigator: Edgardo Santos
Phone: 561-955-5630
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Osama Rahma
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Carolyn Britten
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Jonathan Moreira
Phone: 312-966-9272
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, Illinois 60612
Principal Investigator: Oana Danciu
Phone: 312-996-2088
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Cincinnati, Ohio 45206
Principal Investigator: John Morris
Phone: 513-584-2951
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11100 Euclid Avenue
Cleveland, Ohio 44106
216.844.8797
Principal Investigator: Jennifer Eads
Phone: 216-286-9210
Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
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Dallas, Texas 75246
Principal Investigator: Minal Barve
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Denver, Colorado 80218
Principal Investigator: Allen Cohn
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Detroit, Michigan 48202
Principal Investigator: Wang Ding
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Duarte, California 91010
Principal Investigator: Marwan Fakih
Phone: 626-218-0171
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Escondido, California 92025
Principal Investigator: Edward McClay
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Alexander Spira
Phone: 703-280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fort Worth, Texas 76104
Principal Investigator: Stephen Richey
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Goodyear, Arizona 85338
Principal Investigator: Glen Weiss
Phone: 480-132-3135
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Greenville, South Carolina 29605
Principal Investigator: William Edenfield
Phone: 864-455-3735
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Hershey, Pennsylvania 17033
Principal Investigator: Nelson Yee
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Houston, Texas 77203
Principal Investigator: Julio Peguero
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Houston, Texas 77030
Principal Investigator: Aung Naing
Phone: 713-794-4625
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Knoxville, Tennessee 37920
Principal Investigator: Russell DeVore
Phone: 865-934-2676
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409 West Circle Drive
Lansing, Michigan 48910
Principal Investigator: Borys Hrinczenko
Phone: 517-975-9539
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Fadi Braiteh
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Konstantin Dragnev
Phone: 603-650-4428
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Metairie, Louisiana 70006
Principal Investigator: Jayne Gurtler
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Miami, Florida 33136
Principal Investigator: Lynn Feun
Phone: 305-243-0863
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Newnan, Georgia 30265
Principal Investigator: Patricia Thompson
Phone: 770-400-7194
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Norfolk, Virginia 23502
Principal Investigator: Paul Conkling
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Norwich, Connecticut 06360
Principal Investigator: Dennis Slater
Phone: 860-886-8362
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Sacramento, California 95817
Principal Investigator: Karen Kelly
Phone: 916-734-5930
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Saint Louis, Missouri 63110
Principal Investigator: Benjamin Tan
Phone: 314-747-5376
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San Antonio, Texas 78229
Principal Investigator: Kyriakos Papadopoulos
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San Antonio, Texas 78258
Principal Investigator: Sharon Wilks
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Ari Baron
Phone: 415-600-1775
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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Tucson, Arizona 85712
Principal Investigator: Bruce Porterfield
Phone: 520-290-2510
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Tyler, Texas 75702
Principal Investigator: Donald Richards
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Vancouver, Washington 98683
Principal Investigator: David Smith
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Westwood, Kansas 66205
Principal Investigator: Stephen Williamson
Phone: 913-945-5052
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Whittier, California 90603
Principal Investigator: Agajanian Richy
Phone: 562-693-4477
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