A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:May 24, 2018
End Date:October 2020
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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A Phase 1a/1b Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics,
pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and
INCB081776 in combination with nivolumab (Part 2).


Inclusion Criteria:

- Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1
that are considered nonamenable to surgery or other curative treatments or procedures.

- Must have received or been intolerant to standard therapy.

- Eastern Cooperative Oncology Group performance status score of 0 or 1.

- Willingness to avoid pregnancy or fathering children as per protocol-defined criteria.

Exclusion Criteria:

- Laboratory values not within the protocol-defined range.

- History of retinal disease as defined in the protocol.

- Clinically significant cardiac disease as per protocol-defined criteria.

- History or presence of an ECG that, in the investigator's opinion, is clinically
meaningful as per protocol-defined criteria.

- Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases
that have progressed as per protocol-defined criteria.

- Active or inactive autoimmune disease or syndrome that has required systemic treatment
in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory
disease.

- Prior Grade 3 or higher immune-related AEs or any ocular toxicity on prior
immunotherapy as per protocol-defined criteria.

- Receipt of any vitamin K antagonists, systemic corticosteroids, live vaccines, or
treatment with any anticancer medications or investigational drugs within the
protocol-defined intervals.

- Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or
complications from prior surgical intervention before starting study treatment.

- Active infection requiring systemic therapy.

- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

- Known history of HIV (HIV 1/2 antibodies).
We found this trial at
6
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Geoffrey Shapiro, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: James Lee, MD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Pittsburgh, PA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Melissa Johnson, MD
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Principal Investigator: Patricia LoRusso, MD
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Curtis Chong, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Philadelphia, Pennsylvania 19104
Principal Investigator: Tara Mitchell, MD
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Philadelphia, PA
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