Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

This is an open-label, FIH study designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-4008, a potent and highly selective fibroblast growth factor receptor 2 (FGFR2) inhibitor administered orally patients with unresectable or metastatic ICC and other unresectable or metastatic solid tumors. This study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).

Official Title

A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

Keywords

Solid Tumor, Adult FGFR2 Amplification FGFR2 Gene Mutation FGFR2 Gene Rearrangement FGFR2 Gene Translocation FGFR2 Gene Activation Intrahepatic Cholangiocarcinoma Cholangiocarcinoma Endometrial Cancer Gastric Cancer Breast Cancer Endometrial Neoplasms RLY-4008

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically or cytologically confirmed unresectable or metastatic solid tumor
  • Documented FGFR2 gene fusion, mutation, or amplification per local testing of blood and/or tumor
  • Additional FGFR2 alterations/tumor types may be considered for the Part 1 dose escalation
  • Part 2 dose expansion patients must additionally meet the group requirements detailed below.
  • Group 1 - Patients must have unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR2 fusion previously treated with a pan-FGFR inhibitor
  • Group 2 - Patients must have unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR2 fusion NOT previously treated with a pan-FGFR inhibitor
  • Group 3 - Patients must have unresectable or metastatic solid tumor with FGFR2 fusion other than ICC
  • Group 4 - Patients must have unresectable or metastatic solid tumor with FGFR2 amplification
  • Group 5 - Patients must have unresectable or metastatic solid tumor with an oncogenic FGFR2 mutation
  • Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy
  • Patient must have measurable or evaluable disease per RECIST v1.1
  • Patient has ECOG performance status of 0-2

You CAN'T join if...

  • Ongoing, clinically significant corneal or retinal disorder
  • Patient has any of the following within 14 days prior to the first dose of RLY-4008:
  • Platelet count < 75 x 109 /L

  • Absolute neutrophil count (ANC) < 1 x 109 /L

  • Hemoglobin < 8 g/dL (red blood cell transfusion and erythropoietin may be used to reach 8 g/dL, but must have been administered at least 2 weeks prior to the first dose of RLY-4008)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x the upper limit of normal (ULN) if no hepatic metastases are present; > 5 x ULN if hepatic metastases are present
  • Total bilirubin > 1.5 x ULN; > 3 x ULN with direct bilirubin > 1.5 x ULN in presence of Gilbert's disease
  • Estimated (Cockcroft-Gault formula) or measured creatinine clearance < 50 mL/min
  • QT interval corrected using Fridericia's formula (QTcF) > 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome
  • Clinically significant, uncontrolled cardiovascular disease
  • CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Relay Therapeutics, Inc.
ID
NCT04526106
Phase
Phase 1
Study Type
Interventional
Last Updated