Brief Title: Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies – (FIGHT-101)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

Primary Outcome 1 - Timeframe: up to 763 days

Primary Outcome 2 - Measure: Part 3: Number of Participants With Any TEAE

Primary Outcome 2 - Timeframe: up to 869 days

Primary Outcome 3 - Measure: E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2

Primary Outcome 3 - Timeframe: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

Primary Outcome 4 - Measure: EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2

Primary Outcome 4 - Timeframe: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

Primary Outcome 5 - Measure: Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2

Primary Outcome 5 - Timeframe: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

Primary Outcome 6 - Measure: Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2

Primary Outcome 6 - Timeframe: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

CONDITION

• Lung Cancer
• Solid Tumor
• Gastric Cancer
• Urothelial Cancer
• Endometrial Cancer
• Multiple Myeloma
• Myeloproliferative Neoplasms
• Breast Cancer
• Cholangiocarcinoma
• UC
• MPN

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Luis Féliz, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION