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Clinical Trial 19820

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT03762447

Phase: Phase I
Principal Investigator:

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Study Title

A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics,and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors



Primary To determine the safety, tolerability, and DLTs of INCB086550. Secondary To evaluate the PK of INCB086550 in participants with advanced solid tumors. To evaluate the pharmacodynamics of INCB086550 in participants with advanced solid tumors. To determine the preliminary efficacy of INCB086550 in participants with advanced solid tumors. Exploratory To explore biomarkers that predict pharmacologic activity. To evaluate biomarker correlations with clinical safety and early efficacy. To evaluate the efficacy of INCB086550 per iRECIST in participants with advanced solid tumors.





INCB086550 ()

Inclusion Criteria

  • Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1 that are considered nonamenable to surgery or other curative treatments or procedures. Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if progression has been demonstrated in the lesion.
  • Must have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to or ineligible for standard treatment. There is no limit to the number of prior treatment regimens.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1.
  • Life expectancy > 12 weeks.
  • Willingness to avoid pregnancy or fathering children
  • Part 2 expansion Cohort 2-A only:
  • Participants with any solid tumor that has an FDA-approved anti PD-1 therapy indication.
  • Participants must have had confirmed disease progression on a prior anti¿PD-1 monoclonal antibody.
  • Disease progression must be documented based on the criteria below:
  • Primary refractory: Must have received prior treatment of an anti PD-1 therapy (alone or as part of a combination) in the advanced or metastatic setting for a minimum of 12 weeks and have PD as their best response to treatment.
  • Secondary resistance: Must have received prior anti PD-1 therapy (alone or as part of a combination) in the advanced or metastatic setting and achieved CR, PR, or SD but later had confirmed PD while receiving anti¿PD-1 therapy (PD confirmed at least 4 weeks [no less than 28 days] later).
  • Part 2 expansion Cohort 2-B only:
  • Participants with any solid tumor with no anti PD-1 approved indication who are immunotherapy naïve.
  • Part 3 MSI-H or dMMR expansion cohort only:
  • Participants with any MSI-H or dMMR solid tumor who are immunotherapy-naïve. Note: MSI or MMR status determined by a local laboratory using IHC, polymerase chain reaction methods, or next-generation sequencing. Note: Participants with brain tumors are excluded

  • Exclusion Criteria

  • Laboratory values not within the Protocol-defined range.
  • 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. Participants who have previously treated and clinically stable brain or CNS metastases and have not required steroids for at least 7 days before study treatment are eligible.
  • Known additional malignancy that is progressing or requires active treatment.
  • Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
  • Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
  • Active infection requiring systemic therapy.
  • Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
  • Known history of HIV (HIV 1/2 antibodies).
  • Known hypersensitivity or severe reaction to any component of study drug or formulation components
  • Part 2 expansion Cohort 2-B and Part 3 only:
  • Prior receipt of immunotherapy including anti PD-1, anti PD-L1, anti CTLA-4, or other immune checkpoint inhibitors (eg, GITR, LAG3, TIM3, OX40, ICOS, IL2, and 41BB).
  • All Cohorts:
  • Receipt of systemic antibiotics within 28 days of first dose of study treatment
  • Probiotic usage during screening and throughout the study treatment

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.