STX-478

DRUG2 trials

Sponsors

Eli Lilly & Co., Eli Lilly and Company

Conditions

Breast CancerBreast NeoplasmsNeoplasm MetastasisSolid Tumors, Adult

Phase 1

First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

RecruitingNCT05768139

Eli Lilly and CompanyBreast Cancer, Solid Tumors, Adult

Start: 2023-04-17End: 2030-07-01Target: 880Updated: 2026-05-22

Phase 3

J6M-MC-JSGD: A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tersolisib (LY4064809) Combined with a CDK4/6 Inhibitor and Endocrine Therapy in Adults with HR+, HER2- Advanced Breast Cancer with a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

Not yet recruitingCTIS2025-522791-92-00

Eli Lilly & Co.Breast Neoplasms, Neoplasm Metastasis

Target: 36Updated: 2026-03-24

Related Papers

Abstract PS1-08-24: A phase 1/2 trial of LY4064809 (STX-478), a pan-mutant-selective PI3Kα inhibitor in HR+, HER2- advanced breast cancer (ABC): Updated results from PIKALO-1

Clinical Cancer Research2026-02-17

Abstract 5977: Identification and characterization of an allosteric and mutant-selective PI3Kα inhibitor

Cancer Research2025-04-21

Abstract PO1-20-04: STX-478-101: A phase 1/2, first-in-human study of STX-478 monotherapy or in combination with fulvestrant in patients with breast cancer or other advanced solid tumors (trial in progress)

Cancer Research2024-05-02

Abstract PO2-18-04: STX-478 is a potentially best-in-class mutant-selective PI3Kα inhibitor that demonstrates robust efficacy in ER+ breast cancer models as monotherapy and in combination with standard of care agents

Cancer Research2024-05-02