Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05216432
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2021-12-20
Brief Title:
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
Sponsor:
Relay Therapeutics Inc
Organization:
Relay Therapeutics Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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-45-bisphosphate-3 kinase catalytic subunit alpha PIK3CA mutation in blood andor tumor per local assessment The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors RLY-2608 fulvestrant and RLY-2608 fulvestrant CDK46 inhibitor palbociclib or ribociclib combination arms for patients with HR HER2- locally advanced or metastatic breast cancer The RLY-2608 single agent arm RLY-2608 fulvestrant combination arm and triple combination arms will have 2 parts a dose escalation Part 1 and a dose expansion Part 2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None