Browse Studies — Arctuva

Phase 3

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor

This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib +…

PIK3CA MutationHER2- Negative Breast CancerHormone Receptor Positive Tumor+3 more

Estimated

~$10 – $8,750

Relay Therapeutics, Inc.NCT06982521

Phase 1

A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations

This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacod…

PIK3CA MutationsAdvanced Solid Tumors, AdultEndometrial Cancer+2 more

Estimated

~$10 – $8,750

Cogent Biosciences, Inc.NCT07383506

Phase 2

A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation

This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (RLY-2608), in adults and chi…

PIK3CA-Related Overgrowth Spectrum (PROS)Lymphatic MalformationsVascular Malformations+5 more

Estimated

~$10 – $8,750

Relay Therapeutics, Inc.NCT06789913

Phase 1

A Phase 1/1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+/HER2- Breast Cancers

This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (…

Breast CancerOvarian CancerEndometrial Cancer+6 more

Estimated

~$10 – $8,750

Regor Pharmaceuticals Inc.NCT07524322

Phase 1

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and pre…

PIK3CA MutationSolid Tumor, AdultHER2-negative Breast Cancer+4 more

Estimated

~$10 – $8,750

Relay Therapeutics, Inc.NCT05216432