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Protocol # 20-577

Status

Recruiting

Description

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).

Condition

  • FGFR2 Amplification
  • FGFR2 Gene Mutation
  • FGFR2 Gene Fusion/Rearrangement
  • FGFR2 Gene Translocation
  • FGFR2 Gene Activation
  • Intrahepatic Cholangiocarcinoma
  • Cholangiocarcinoma
  • Other Solid Tumors, Adult

Interventions

  • RLY-4008

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Objective Response Rate (ORR) assessed per RECIST v1.1
  • Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-4008
  • Number of patients with adverse events and serious adverse events

Secondary Outcome:

  • Duration of Response (DOR) assessed per RECIST v1.1
  • FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue
  • Disease Control Rate (DCR) as assessed by RECIST v1.1
  • Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)
  • Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)
  • Pharmacokinetic parameters including half-life (t1/2)
  • Pharmacodynamic parameters including changes in fibroblast growth factor 23 (FGF-23)
  • Pharmacodynamic parameters including changes in carcinoembryonic antigen (CEA)
  • Pharmacodynamic parameters including changes in cancer antigen 19-9 (CA 19-9)

Enrollment

400

Study Start Date

September 2, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Relay Therapeutics, Inc.

Source

Relay Therapeutics, Inc.

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

Clinicaltrials.gov Identifier

NCT04526106

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.