A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:March 28, 2016
End Date:December 2020
Contact:Beth Zaharoff, Director, Patient Focus
Email:bzaharoff@tesarobio.com

Use our guide to learn which trials are right for you!

This is a multicenter, open-label, first-in-human Phase 1 study evaluating the
anti-programmed death receptor 1 (anti-PD-1) antibody TSR-042 in patients with advanced solid
tumors who have limited available treatment options. The study will be conducted in 2 parts:
dose escalation and cohort expansion. The cohort expansion may include various tumor types,
including endometrial, Non-Small Cell Lung cancer, and MSI-H solid tumors.


Inclusion Criteria:

- Patient is at least 18 years of age

- Patient with advanced or metastatic solid tumor and has disease progression after
treatment who are intolerant to treatment that meets the following requirements for
the part of the study they will participate in:

1. Part 1: Patient with any advanced or metastatic solid tumor

2. Part 2A: Patient with any advanced or metastatic solid tumor

3. Part 2B: Patient with Non-Small Cell Lung Cancer (NSCLC), Endometrial cancers,
and MSI-H solid tumors.

- Female patients, if of childbearing potential, must have a negative serum pregnancy
test within 72 hours prior to the date of the first dose of study medication.

- Female patients of childbearing potential must agree to use 2 adequate methods of
contraception with their partner starting with the screening visit through 150 days
after the last dose of study therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 for Part 1 and ≤ 1
for Part 2. Adequate organ function.

Exclusion Criteria:

- Patient has received prior therapy with an anti- programmed death receptor 1
(anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD- L2)
agent.

- Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous
meningitis. Note: Patients with previously treated brain metastases may participate
provided they are stable (without evidence of progression by imaging for at least 4
weeks prior to the first dose of study treatment and any neurologic symptoms have
returned to baseline), have no evidence of new or enlarging brain metastases, and are
clinically stable off steroids for at least 7 days prior to study treatment.
Carcinomatous meningitis precludes a patient from study participation regardless of
clinical stability.

- Known additional malignancy that progressed or required active treatment within the
last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell
cancer (SqCC) of the skin that has undergone potentially curative therapy, or in situ
cervical cancer.

- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).

- Known active hepatitis B (eg, hepatitis B surface antigen [HBsAg] reactive) or
hepatitis C (eg, hepatitis C virus ribonucleic acid (HCV RNA) (qualitative) is
detected).

- Active autoimmune disease that has required systemic treatment in the past 2 years
(ie, with use of disease- modifying agents, corticosteroids, or immunosuppressive
drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment.

- History of interstitial lung disease.
We found this trial at
49
sites
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Calgary,
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
?
mi
from
Farmington, NM
Click here to add this to my saved trials
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
Goodyear, Arizona 85395
Phone: 623-207-3183
?
mi
from
Goodyear, AZ
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jamaica, NY
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92660
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Providence, RI
Click here to add this to my saved trials
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78224
Phone: 210-593-5252
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
Scottsdale, Arizona
Phone: 480-323-1339
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Westwood, KS
Click here to add this to my saved trials