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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

Published: February 21, 2020

Study Start DatePrimary Outcome Measures

  1.  Number of treatment-emergent adverse events [ Time Frame: Up to approximately 25 months ]
      Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 30 days after last dose of study drug.

Secondary Outcome Measures

  1. Cmax of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Maximum observed plasma concentration
  2. tmax of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Time to maximum plasma concentration
  3. Cmin of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Minimum observed plasma concentration over the dose interval
  4. AUC0-t of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t
  5. t½ of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Apparent terminal-phase disposition half-life
  6. λz of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Terminal elimination rate constant
  7. Oral Clearance (CL/F) of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Oral dose clearance
  8. Vz/F of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Apparent oral dose volume of distribution

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 (ECOG) 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 ECG 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 intervals before the first administration of study drug.
  • A 28-day washout for systemic antibiotics is required.
  • Probiotic usage while on study and during screening is prohibited.
  • Active infection requiring systemic therapy.
  • Known history of HIV
  • Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
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