A Phase 1a/b study of LOXO-435 in Advanced Solid Tumor Malignancies with FGFR3 Alterations

• Research type

  Research Study

• Full title

  An Open-label, multicenter Phase 1a/b Study of LOXO-435 in Advanced Solid Tumor Malignancies with FGFR3 Gene Alterations

• IRAS ID

  1006909

• Contact name

  Chelsey-Montana Guy

• Contact email

  UK-Regulatory@medpace.com

• Sponsor organisation

  Loxo Oncology, Inc. on behalf of Eli Lilly and Company

• Research summary

  LOXO-435 is an investigational drug, taken orally, for the treatment of solid cancers with a particular genetic abnormality or alteration (called a mutation, fusion, amplification or overexpression) of a gene called FGFR3. This study will be the first time LOXO-435 will be taken by humans. The information gained from this study may help doctors learn more about LOXO-435 as a potential treatment for cancers that have an FGFR3 alteration.
  The trial will try to answer the questions: “What is the recommended dose of LOXO-435 for the treatment of cancers with an FGFR3 alteration by itself or in combination with an anti-cancer therapy that should be tested in future studies?” and “Is the investigational treatment LOXO-435 safe and effective for the treatment of cancers with an FGFR3 alteration by itself or in combination with an anti-cancer therapy?”.
  There will be two parts to the study, dose escalation and dose expansion. During dose escalation, LOXO-435 will be studied at different total daily dose levels in groups called cohorts where each group will be assigned to a different dose and/or dose schedule. Patients will take part in one of these as per their doctor’s discretion in consultation with the Sponsor. In the dose escalation phase patients will be treated with LOXO-435 alone. The main objective of the dose escalation phase is to establish the recommended dose of Loxo-435. That recommended dose will be then applied to all patients included in the dose expansion phase. In the dose expansion phase, patients will be treated with LOXO-435alone or in combination with an anti-cancer drug called pembrolizumab.Patients will continue to receive LOXO-435 as long as their cancer is responding to treatment, and they are not having any intolerable or severe side effects. For patients taking LOXO-435 and pembrolizumab, they will receive pembrolizumab for a maximum of 2 years or 35 cycles.It is expected that up to 140people will take part in this research studyworldwide

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  23/NE/0085

• Date of REC Opinion

  19 Jun 2023

• REC opinion

  Further Information Favourable Opinion