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Protocol # 21-689

Status

Recruiting

Description

This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate both RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors and RLY-2608 + fulvestrant combination arm for patients with HR+ HER2- locally advanced or metastatic breast cancer. This study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).

Condition

  • PIK3CA Mutation
  • Solid Tumor, Adult
  • HER2-negative Breast Cancer
  • Breast Cancer
  • Metastatic Breast Cancer
  • Advanced Breast Cancer
  • Unresectable Solid Tumor

Interventions

  • RLY-2608
  • Fulvestrant

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-2608 as a single agent
  • Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-2608 in combination with fulvestrant
  • Number of patients with adverse events and serious adverse events of RLY-2608 as a single agent
  • Number of patients with adverse events and serious adverse events of RLY-2608 in combination with fulvestrant

Secondary Outcome:

  • PIK3CA gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue
  • Pharmacokinetic parameters including maximum plasma drug concentration (Cmax) of RLY-2608 (and its metabolites, as appropriate) as single agent
  • Pharmacokinetic parameters including area under the plasma concentration versus time curve from time 0 to 24 hours postdose (AUC0-24) of RLY-2608 (and its metabolites, as appropriate) as single agent
  • Pharmacokinetic parameters including terminal elimination half-life (t1/2) of RLY-2608 (and its metabolites, as appropriate) as single agent
  • Pharmacokinetic parameters including maximum plasma drug concentration (Cmax) of RLY-2608 (and its metabolites, as appropriate) when RLY-2608 is administered in combination with fulvestrant
  • Pharmacokinetic parameters including area under the plasma concentration versus time curve from time 0 to 24 hours postdose (AUC0-24) of RLY-2608 (and its metabolites, as appropriate) when RLY-2608 is administered in combination with fulvestrant
  • Pharmacokinetic parameters including terminal elimination half-life (t1/2) of RLY-2608 (and its metabolites, as appropriate) when RLY-2608 is administered in combination with fulvestrant
  • Changes in circulating blood of fasting glucose in RLY-2608 as a single agent
  • Changes in circulating blood of insulin in RLY-2608 as a single agent
  • Changes in circulating blood of C-peptide in RLY-2608 as a single agent
  • Changes in circulating blood of HbA1c in RLY-2608 as a single agent
  • Changes in circulating blood of fasting glucose in RLY-2608 in combination with fulvestrant
  • Changes in circulating blood of insulin in RLY-2608 in combination with fulvestrant
  • Changes in circulating blood of C-peptide in RLY-2608 in combination with fulvestrant
  • Changes in circulating blood of HbA1c in RLY-2608 in combination with fulvestrant
  • Overall response rate (ORR) as assessed by RECIST v1.1
  • Duration of Response (DOR) as assessed by RECIST v1.1
  • Disease Control Rate (DCR) as assessed by RECIST v1.1
  • Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)

Enrollment

235

Study Start Date

December 8, 2021

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 Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer

Clinicaltrials.gov Identifier

NCT05216432

     

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.