A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors



Status:Recruiting
Conditions:Colorectal Cancer, Ovarian Cancer, Cervical Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/17/2018
Start Date:November 20, 2017
End Date:May 27, 2020
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors

The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in
combination with chemotherapy in participants with advanced/metastatic solid tumors.


Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of selected advanced or metastatic
solid tumors.

- Presence of measurable disease per RECIST v1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Baseline archival tumor specimen available or willingness to undergo a pretreatment
tumor biopsy to obtain the specimen.

- Resolution of treatment-related toxicities.

- Adequate hepatic, renal, cardiac, and hematologic function.

- Additional cohort-specific criteria may apply.

Exclusion Criteria:

- Subjects who participated in any other study in which receipt of an investigational
study drug or device occurred within 28 days or 5 half-lives (whichever is longer)
prior to first dose.

- Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is
shorter) before administration of study drug.

- Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before
administration of study treatment.

- Has received prior approved radiotherapy within 14 days of study therapy.

- Has had known additional malignancy that is progressing or requires active treatment,
or history of other malignancy within 2 years of study entry.

- Has an active autoimmune disease that has required systemic treatment in past 2 years.

- Has an active infection requiring systemic therapy.

- Has known active CNS metastases and/or carcinomatous meningitis.

- Women who are pregnant or breastfeeding.
We found this trial at
7
sites
Birmingham, Alabama 35294
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Marietta, Georgia 30060
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Marietta, GA
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Mobile, Alabama 36604
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Mobile, AL
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Sacramento, California 95817
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Sacramento, CA
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4383 Medical Drive
San Antonio, Texas 78229
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San Antonio, TX
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