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

Updated on 10 May 2022
measurable disease
solid tumors
solid tumor
metastatic cancer


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.



For more information, please contact Incyte Corporation at 1.855.463.3463 or visit www.incyteclinicaltrials.com

Condition Cancer/Tumors, Solid Tumors, Metastatic Cancer
Clinical Study IdentifierTX225646
Last Modified on10 May 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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