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): Esophageal
  • Phase(s): I
  • 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;
  • Part 2 (Dose Expansion):
  • Subjects with measurable disease with documented FGF/FGFR alteration in tumor types that include squamous NSCLC, gastric cancer/cholangiocarcinoma, urothelial cancer, endometrial/breast cancer, multiple myeloma, MPNs, or other tumor types that have been evaluated to harbor genetic alterations in FGF or FGFR genes. Medical monitor approval is needed for subjects with tumor types other than squamous NSCLC, gastric cancer/cholangiocarcinoma, urothelial cancer, and endometrial/breast cancer.
  •  Part 3:
  • 1) Dose finding: subjects with solid tumor malignancies that have measurable disease for which treatment with gemcitabine + cisplatin, docetaxel, or pembrolizumab 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, or pembrolizumab 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 21 days or 5 half-lives(whichever is longer) 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.
  • If previous treatment is allowed based on medical monitor approval, 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 and/or current evidence of ectopic mineralization/calcification including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification.
  • Current evidence of corneal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuctivitis, etc., 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.


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