IRB #

STUDY00016716

Title

(TESARO 4010-01-001) A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors

Principal Investigator

Koenraad De Geest

Study Purpose

This is a research study to test a new investigational drug. An investigational drug is one that is not yet approved by any regulatory authorities, such as the United States Food and Drug Administration (FDA). The investigational drug being studied here is called TSR-042, and is an anti-programmed cell death-1 (anti-PD-1) antibody, designed to help the immune system recognize and attack cancer cells.

This is a Phase 1 study that is being carried out in 3 parts; currently, the study is enrolling into the final stage, Part 2B, with a main purpose of evaluating the ability of the investigational drug to reduce the size of tumors in patients with specific cancer types, including endometrial cancer.

Medical Condition(s)

Endometrial cancer

Eligibility Criteria

1. Histologically or cytologically proven advanced (unresectable) or metastatic endometrial cancer (all histologies are allowed except endometrial sarcoma)

2. Progression of disease on or after at least 1, but no more than 2, lines of anti-cancer therapy (at least 1 must have been platinum-based, and prior treatment with hormone therapies do not count toward this number); evidence of progression by two radiographic imaging studies/scans must be available for submission to the study sponsor

3. Availability of formalin-fixed, paraffin-embedded archival tumor tissue from a previous surgery/biopsy; or, if unavailable, agreement to a new biopsy to obtain a tissue sample from an easily accessible tumor lesion prior to study treatment initiation

Other eligibility criteria will also apply.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Treatment can continue for up to 2 years, or until disease progression, unacceptable toxicity, patient withdrawal, investigator decision, or death. Continued treatment with the study drug beyond 2 years may be considered following discussion between the investigators and the study sponsor.
After treatment ends, you will be followed for safety assessments every 90 days via telephone.

Minors Included

No

Contact

Yukie Bean, CCRP
Gyn/Onc Study Coordinator
503.418.4522

Sponsor

TESARO, Inc.

Recruitment End

01/01/2020

Compensation Provided

No


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