| ClinicalTrials.gov Identifier |
| NCT05242822 |
| Institution Name |
| Multiple Sites (see below), Kinnate Biopharma Inc. (Sponsor) |
| Institution Country |
| United States |
| Institution Website |
| https://clinicaltrials.gov/ct2/show/NCT05242822 |
| Additional Institutions |
- Please Visit https://clinicaltrials.gov/ct2/show/NCT05242822 for detailed information regarded the sites
- Sarah Cannon Research Institute, Recruiting
Lake Nona, Orlando, Florida, 32827
asksarah@sarahcannon.com
- START Midwest, Recruiting
Grand Rapids, Michigan, 49546
yvette.cole@startmidwest.com
- Sarah Cannon Research Institute, Recruiting
Nashville, Tennessee, 37203
asksarah@sarahcannon.com
|
| Principal Investigator |
| Multiple Sites |
| Principal Investigator Phone |
| (816) 614-3663 |
| Principal Investigator Email |
| clinicaltrials@kinnate.com |
| Additional Principal Investigators |
| Please Visit https://clinicaltrials.gov/ct2/show/NCT05242822 for detailed information regarded the sites |
| Study Coordinator |
| Multiple Sites |
| Study Coordinator Phone |
| (816) 614-3663 |
| Study Coordinator Email |
| clinicaltrials@kinnate.com |
| Additional Study Coordinators |
| Please Visit https://clinicaltrials.gov/ct2/show/NCT05242822 for detailed information regarded the sites |
| Study Overview |
| This is an open label study in adults with advanced tumors who have FGFR2 and/or FGFR3 mutations. Participants receive daily medicine by mouth of KIN-3248 (study drug) with periodic study visits (ranging from weekly at the beginning of the trial to monthly) to have laboratory testing, imaging assessments and safety exams such as ECG, physical exam |
| Enrollment Information |
| 120 patient participants |
| Study Start Date |
| 20220401 |
| Study End Date |
| 20260901 |
| Study Purpose |
- The study drug, KIN-3248, belongs to a group of anti-cancer drugs called FGFR inhibitors. Cancer can form when there are changes (mutations) in the FGFR gene. FGFR mutations are found in cholangiocarcinoma, and bladder cancers specifically, but have also been detected in other cancers as well. This study is divided into two parts:
- Part A will look at the safety of different doses of the study drug to determine which dose should be used in Part B.
- Part B will continue to look at the safety of the chosen dose of the study drug from Part A and test whether it can slow down or stop a cancer tumor from growing.
|
| Inclusion Criteria |
- Provide written informed consent prior to initiation of any study-specific procedures
- Have advanced stage solid tumor with known FGFR2 and/or FGFR3 gene alteration, as confirmed by previous genomic analysis of tumor tissue or ctDNA
- Have measurable or evaluable disease according to RECIST v1.1
- Have an ECOG performance status 0 or 1
- Have adequate organ function, as measured by laboratory values (criteria listed in protocol)
- Be able to swallow, retain, and absorb medications taken by mouth
|
| Exclusion Criteria |
- Have known clinically-active or clinically-progressive brain metastases from non-brain tumors
- Have a history and/or current evidence of abnormal calcium-phosphorous homeostasis, ectopic mineralization or calcification, or corneal or retinal disorder/keratopathy
- Have GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease
- Have active, uncontrolled bacterial, fungal, or viral infection
- Be women who are lactating or breastfeeding, or pregnant
|
| Financial Assistance Available |
| No |
