Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With A… (NCT04242199) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
United States182 participantsStarted 2020-09-04
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
* Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
* Eastern Cooperative Oncology Group performance status score of 0 or 1.
* Life expectancy \> 12 weeks.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
* Laboratory values outside the Protocol-defined ranges.
* Clinically significant cardiac disease.
* History or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful.
* Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
* Known additional malignancy that is progressing or requires active treatment.
* Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.
* Prior receipt of an anti-PD-L1 therapy.
* Treatment with anticancer medications or investigational drugs within protocol-defined interv…