MC# 15-03 - A Phase I/II, Open-Label, Dose Escalation, Safety, and Tolerability Study of INCB054828 in Subjects with Advanced Malignancies

  • Agent(s): INCB054828
  • Disease Type(s): Bladder, Head and Neck, Solid Tumor, Lung-NSCLC
  • Phase(s): I, II
  • Drug Classification(s): Targeted Therapy, Small Molecule
  • Molecular Target(s): FGF, FGFR

Mechanism of Action

INCB054828 is an inhibitor of the kinase FGFR


The purpose of this study is to test an investigational drug called INCB054828.

Inclusion Criteria
  • Male or female subjects, age 18 years or older on day of signing consent
  • Willingness to provide written informed consent for the study
  • Part 1:
  • Any advanced solid tumor malignancy
  • Subset subjects with moderate renal impairment and severe renal impairment
  • Part 2 (Dose Expansion):
  • Subjects with measurable disease with documented FGF/FGFR alterations, including multiple myeloma and MPNs.  For subjects enrolling in Part 2 with head and neck, vulvar, or anal cancer, must have evidence of positive HPV status.
  • Part 3:
  • 1) Dose finding: subjects with solid tumor malignancies that have measurable disease for which treatment with gemcitabine + cisplatin, docetaxel, trastuzumab, and PD-1-directed therapies is relevant
  • 2) Dose expansion: subjects with solid tumor malignancies that have measurable disease and are also harboring FGF/FGFR alterations for which treatment with gemcitabine + cisplatin, docetaxel, trastuzumab, and PD-1-directed therapies is relevant
  • Has progressed after prior therapy and either there is no further effective standard anticancer therapy available (including if subject refuses or is intolerant) or the prescribed combination therapy for subjects enrolling in Part 3 is considered a relevant therapy for their diagnosis
  • Life expectancy > 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status:
    • Part 1: 0 or 1
    • Part 2: 0, 1, or 2
    • Part 3: 0, 1, or 2
Exclusion Criteria
  • Treatment with other investigational study drug for an indication for any reason, or receipt of anticancer medications within 28 days before first dose of study drug (6 weeks for mitomycin-C or nitrosoureas, 7 days for tyrosine kinase inhibitors) but may be eligible with approval from the sponsor's medical monitor.
  • Subjects must have recovered (≤ Grade 1 or pretherapy baseline) from adverse events (AEs) due to previously administered therapies
  • Prior receipt of a selective FGFR inhibitor within the last 6 months
  • History of calcium and phosphate homeostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues, such as the skin, kidney, tendons, or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance)
  • Current evidence of clinically significant corneal disorder/keratopathy (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuctivitis), or retinal disorder (including but not limited to macular/retinal degeneration, diabetic retinopathy, retinal detachment), confirmed by ophthalmologic examination
  • Prior radiotherapy within 2 weeks of study treatment.  Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.  Evidence of fibrosis within a radiation field from prior radiotherapy is permitted with medical monitor approval.  A 1-week washout period is permitted for palliative radiation to non–central nervous system (CNS) disease with medical monitor approval.
    • Subjects enrolled into Part 3 (pembrolizumab or INCMGA00012 combination), should have a minimum of a 6-month washout period after thoracic radiotherapy if > 30 Gy was received


  • Dallas, TX - Mary Crowley Cancer Research - Medical City
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Re: MC# 15-03