An Open-Label, Dose-Escalation, Safety Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/2/2018
Start Date:April 2016
End Date:August 2019
Contact:Incyte Corporation Call Center
Phone:1.855.463.3463

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A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors

This is an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in subjects with
advanced or metastatic solid tumors that will be conducted in 2 parts. Part 1 will determine
the pharmacologically active dose and/or maximum tolerated dose of INCAGN01876. Part 2 will
further evaluate the recommended dose determined in Part 1 in subjects with select tumor
types.


Inclusion Criteria:

- Locally advanced or metastatic disease; locally advanced disease must not be amenable
to resection with curative intent

- Part 1: Subjects with advanced or metastatic solid tumors

- Part 2: Subjects with advanced or metastatic adenocarcinoma of endometrium, melanoma,
non-small cell lung cancer, and renal cell carcinoma

- Subjects who have disease progression after treatment with available therapies that
are known to confer clinical benefit, or who are intolerant to treatment, or subjects
who refuse standard treatment

- Presence of measureable disease based on RECIST v1.1

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria:

- Laboratory and medical history parameters not within the protocol-defined range

- Receipt of anticancer medications or investigational drugs within protocol-defined
intervals before the first administration of study drug

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

- Receipt of a live vaccine within 30 days of planned start of study therapy

- Active autoimmune disease

- Prior treatment with any tumor necrosis factor super family agonist

- Known active central nervous system metastases and/or carcinomatous meningitis

- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease

- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation
We found this trial at
8
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Dr. Frank Hodi
Phone: 617-632-9280
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Dr. Dana Cardin
Phone: 615-875-7143
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Dr. Frank Hodi
Phone: 617-632-6287
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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500 Westchester Avenue
Harrison, New York 10604
Principal Investigator: Dr. James Harding
Phone: 646-888-4440
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Harrison, NY
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Los Angeles, California 90025
Principal Investigator: Dr. Omid Hamid
Phone: 310-231-2115
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Los Angeles, CA
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Middletown, New Jersey 07748
Principal Investigator: Dr. James Harding
Phone: 646-888-4440
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Middletown, NJ
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Dr. LoRusso
Phone: 203-737-1889
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Dr. James Harding
Phone: 646-888-4440
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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from
New York, NY
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