Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, PK, PDy, and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic CCA and other solid tumors. The study consists of 3 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3).

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

FGFR2 Amplification, FGFR2 Gene Mutation, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Translocation, FGFR2 Gene Activation, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma, Other Solid Tumors, Adult, RLY-4008, Extension

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
  • Patient must have measurable disease per RECIST v1.1
  • Patient has ECOG performance status of 0-1
  • 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 (except for Group 6, as defined below)
  • Part 2 dose expansion patients with Cholangiocarcinoma:
  • Group 1: CCA patients with an FGFR2 fusion previously treated with an FGFRi
  • Group 2: CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi
  • Group 6: CCA patients with an FGFR2 fusion with no prior chemotherapy and not previously treated with an FGFRi. Prior adjuvant/neo-adjuvant treatment completed >6 months before enrollment is acceptable. A single cycle of palliative chemotherapy is allowed during screening
  • Group 7: CCA patients with an FGFR2 mutation or amplification
  • Part 2 dose expansion patients with other solid tumors (NOT Cholangiocarcinoma):
  • Group 3: Non-CCA patients with an FGFR2 fusion
  • Group 4: Non-CCA patients with an FGFR2 amplification
  • Group 5: Non-CCA patients with an FGFR2 mutation
  • Part 3 extension:
  • CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi

You CAN'T join if...

  • Ongoing, clinically significant FGFRi-induced retinal detachment or an ongoing clinically significant corneal or retinal disorder
  • Patient does not have adequate organ function (defined in protocol)
  • Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol)
  • 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 1/2 research study
Study Type
Interventional
Participants
Expecting 440 study participants
Last Updated