Search Cancer Clinical Trials
Recruiting
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).
- PIK3CA Mutation
- Solid Tumor, Adult
- HER2-negative Breast Cancer
- Breast Cancer
- Metastatic Breast Cancer
- Advanced Breast Cancer
- Unresectable Solid Tumor
- RLY-2608
- Fulvestrant
Phase 1
Interventional
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)
235
December 8, 2021
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Relay Therapeutics, Inc.
Relay Therapeutics, Inc.
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
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.