Purpose

The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female subjects, age 18 years or older on day of signing consent 2. 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 3. Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant) 4. Life expectancy > 12 weeks 5. Eastern Cooperative Oncology Group (ECOG) performance status: - Part 1: 0 or 1 - Part 2 and 3: 0, 1, or 2

Exclusion Criteria

  1. 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 2. Prior receipt of a selective FGFR inhibitor 3. History of a calcium/phosphate homeostasis disorder 4. History and/or current evidence of ectopic mineralization/calcification 5. Current evidence of corneal disorder/keratopathy 6. Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range 7. Prior radiotherapy within 2 weeks of study treatment

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation
Open-label dose escalation with an accelerated titration design based on observing each dose level for a period of 21 days. Dose Expansion Combination therapy: Gemcitabine + Cisplatin + Pemigatinib Pembrolizumab + Pemigatinib Docetaxel + Pemigatinib Trastuzumab + Pemigatinib INCMGA00012 + Pemigatinib
  • Drug: Pemigatinib
    Other names:
    • INCB054828
  • Drug: Gemcitabine + Cisplatin
  • Drug: Pembrolizumab
  • Drug: Docetaxel
  • Drug: Trastuzumab
  • Drug: INCMGA00012

Recruiting Locations

University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama 35205

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Call Center
1-855-463-3463

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.