Open-Label, Dose-Escalation Study of INCB054828 in Subjects With Advanced Malignancies FIGHT-101

What's the purpose of this trial?

The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in patients with advanced malignancies.

This trial is currently open and accepting patients.

What will happen during the trial?


You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Male or female subjects, age 18 years or older on day of signing consent
  • Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
  • Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
  • Life expectancy > 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status:
    • Part 1: 0 or 1
    • Part 2 and 3: 0, 1, or 2

Exclusion Criteria:

  • Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
  • Prior receipt of a selective FGFR inhibitor
  • History of a calcium/phosphate homeostasis disorder
  • History and/or current evidence of ectopic mineralization/calcification
  • Current evidence of corneal disorder/keratopathy
  • Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
  • Prior radiotherapy within 2 weeks of study treatment

Additional Trial Information

Phase 1/2

Enrollment: 256 patients (estimated)

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Published Results

Preliminary results from a phase 1/2 study of INCB054828, a highly selective fibroblast growth factor receptor (FGFR) inhibitor, in patients (pts) with advanced malignancies

January 01, 2018

In part 1, no pts had a complete response (CR) or partial response (PR); 9 and 8 pts had stable disease (SD) and progressive disease (PD), respectively. In part 2, most common tumors were cholangiocarcinoma (CCA; n=9), breast (n=8), and esophageal, ovarian, and head and neck (each n=3); 3 pts (with CCA) had a PR (9 mg QD, n=1; 13.5 mg QD, n=2); 9 and 14 pts had SD and PD, respectively.

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.


Hematology Oncology Associates of the Treasure Coast

Port St. Lucie, FL

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting


Mary Crowley Cancer Research Centers

Dallas, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

START South Texas Accelerated Research Therapeutics

San Antonio, TX

Open and Accepting
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