A Study To Evaluate KIN-3248 In Participants With Advanced Tumors Harboring FGFR2 And//or FGFR3 Gene Alterations

Overview

About this study

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary effectiveness of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Provide written informed consent prior to initiation of any study-specific procedures

- Advanced stage solid tumor

- Known FGFR2 and/or FGFR3 gene alteration, as confirmed by previous genomic analysis of
tumor tissue or ctDNA

- Measurable or evaluable disease according to RECIST v1.1

- ECOG performance status 0 or 1

- Adequate organ function, as measured by laboratory values (criteria listed in
protocol)

- Able to swallow, retain, and absorb oral medications

Exclusion Criteria:

- Known clinically-active or clinically-progressive brain metastases from non-brain
tumors

- History and/or current evidence of abnormal calcium-phosphorous homeostasis, ectopic
mineralization or calcification, or corneal or retinal disorder/keratopathy

- GI tract disease causing an inability to take oral medication, malabsorption syndrome,
requirement for intravenous alimentation, or uncontrolled inflammatory GI disease

- Active, uncontrolled bacterial, fungal, or viral infection

- Women who are lactating or breastfeeding, or pregnant

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Hani Babiker, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Zhaohui Jin, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20535563

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