Primary Outcomes:

Primary Outcome 1 - Measure: Determination of the maximum tolerated dose of Pemigatinib as a monotherapy and in combination as measured by the number of participants with adverse events

Primary Outcome 1 - Time Frame: from baseline through 21 days

Primary Outcome 2 - Measure: Assess the pharmacodynamics of pemigatinib as a monotherapy and in combination as indicated by serum phosphorus level

Primary Outcome 2 - Time Frame: up to 30 days (+ 5 days) follow-up visit

Condition:

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

Eligibility

Criteria:
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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No