A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors (NCT03314935) | Clinical Trial Compass
CompletedPhase 1/2
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
United States149 participantsStarted 2017-11-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Timeframe: up to 1385 days
2
Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)
Timeframe: up to Day 28
3
Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen