A Phase 1/1b Open-label Multicenter Study to Investigate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Anti-tumor Activity of KIN-3248 in Participants with Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Advanced Tumors Harboring Fgfr2 And/or Fgfr3 Gene Alterations
  • Age: Between 18 years - 100 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    In order to participate in this study the following criteria must be met: 1) Participants must have either received prior standard of care therapy (including FGFR-related agents approved in local jurisdictions) appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, be unlikely to tolerate or to derive clinically meaningful benefit from standard of care therapy. 2) Participant’s tumor has documented FGFR2 and/or FGFR3 alterations (see Appendix B) in blood and/or tumor per local assessment as detected by DNA sequencing using a comprehensive next-generation sequencing assay (e.g., FoundationOne® CDx or Guardant360® CDx), break-apart fluorescence in situ hybridization (FISH), or other validated assay. 3) Willing to undergo pre-treatment tumor biopsy, if medically feasible. The availability of a FFPE tumor biopsy specimen obtained within 2 months prior to consent from participants who have not received intervening systemic anti-cancer therapy will satisfy the pretreatment biopsy requirement.

You may not be eligible for this study if the following are true:

  • You will not be able to participate in this study if you have had: 1) Known clinically active or progressive brain metastases. Participants who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to Cycle 1 Day 1 are eligible if they meet all of the following criteria: • Residual neurological symptoms Grade = 2 • On stable doses of dexamethasone (i.e., no increase in dose for preceding 14 days), if applicable AND • No new lesions in the brain appearing on most recent magnetic resonance imaging (MRI) 2) History and/or current evidence of any of the following disorders: • Non-tumor related alteration of calcium-phosphorous homeostasis that is considered clinically significant in the opinion of the investigator • Ectopic mineralization/calcification, including but not limited to soft tissue, kidney, intestine, or myocardia and lung, considered clinically significant in the opinion of the investigator.

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