A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies

  • STATUS
    Recruiting
  • sponsor
    Incyte Corporation
Updated on 24 November 2021
solid tumors
solid tumor
advanced solid tumor
malignant solid tumor

Summary

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies

Description

The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of INCB054828 in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).

For more information, please contact Incyte Corporation at 1.855.463.3463.

Details
Condition Solid Tumors
Clinical Study IdentifierTX145636
SponsorIncyte Corporation
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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