A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors



Status:Completed
Conditions:Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:October 2016
End Date:March 26, 2019

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A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

The purpose of this study is to determine the safety and tolerability and assess preliminary
efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.


Inclusion Criteria:

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

- Subjects who have disease progression after treatment with available therapies that
are known to confer clinical benefit, or who are intolerant to treatment, or who
refuse standard treatment. There is no limit to the number of prior treatment
regimens.

- Part 1: Subjects with advanced or metastatic solid tumors.

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

- Presence of measureable disease based on RECIST v1.1.

- Eastern Cooperative Oncology Group performance status 0 or 1.

Exclusion Criteria:

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

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

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

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

- Active autoimmune disease that required systemic treatment in the past.
We found this trial at
5
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Dr. Davis
Phone: 615-875-7693
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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115-117 Calle Natzaret
Barcelona, 08035
Principal Investigator: Dr. Martin Liberal
Phone: (+34) 93 274 60 00
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Barcelona,
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Houston, Texas 77030
Principal Investigator: Dr. Naing
Phone: 713-794-6047
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Houston, TX
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126 College Avenue
New Brunswick, New Jersey 08901
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New Brunswick, NJ
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New York, New York 10016
Principal Investigator: Dr. Cho
Phone: 212-263-4428
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New York, NY
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