RLY-5836 / Relay Therap - LARVOL DELTA

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=41 | Completed | Sponsor: Relay Therapeutics, Inc. | Active, not recruiting ➔ Completed | N=265 ➔ 41

Enrollment change • Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=265 | Active, not recruiting | Sponsor: Relay Therapeutics, Inc. | Trial completion date: Jul 2024 ➔ May 2025 | Trial primary completion date: Jun 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=265 | Active, not recruiting | Sponsor: Relay Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ Jul 2024 | Trial primary completion date: Dec 2025 ➔ Jun 2024

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

A first-in-human study of the highly selective PI3Kα inhibitor RLY-5836 in patients with advanced breast cancer and other solid tumors (SABCS 2023) - P1 | "Alpelisib, a non-selective orthosteric PI3Kα inhibitor, is approved in combination with fulvestrant for patients with PIK3CA-mutant, ER+, HER2– advanced breast cancer...It is molecularly distinct with differentiated pharmaceutical properties compared to RLY-2608...This study (NCT05759949) is enrolling in the United States. For further information, please contact clinicaltrials@relaytx.com."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA

Relay Therapeutics Reports First Quarter 2023 Financial Results and Corporate Highlights (GlobeNewswire) - "Recent Corporate Highlights:...(i) RLY-5836 (pan-mutant and isoform-selective PI3Kα inhibitor): In April 2023, initiated a first-in-human trial in patients with advanced solid tumors with a PIK3CA (PI3Kα) mutation; (ii) RLY-2139 (CDK2 inhibitor): Selected development candidate; anticipate early 2024 clinical start, pending regulatory authorization."

New molecule • New trial • Trial status • Breast Cancer • Oncology • Solid Tumor

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Relay Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Not yet recruiting | Sponsor: Relay Therapeutics, Inc.

Combination therapy • Metastases • New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

Relay Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Highlights (Yahoo News) - "RLY-4008: Full dose escalation data in the first half of 2023; Complete enrollment of pivotal cohort in the second half of 2023; Data from non-CCA expansion cohorts in the second half of 2023; Breast Cancer; RLY-2608: initial clinical data from dose escalation portions of monotherapy and combination arms of trial in the first half of 2023; RLY-5836: clinical start in the second quarter of 2023; ERα degrader: development candidate nomination in 2023; Selective CDK2 inhibitor: clinical start in early 2024..."

Enrollment status • New trial • P1 data • P1/2 data • Pipeline update • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

First-in-human global multi-center study of RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor, as a single agent in patients with advanced solid tumors and in combination with fulvestrant in patients with advanced breast cancer. (ASCO 2022) - P1 | "Toxicity related to non-selective inhibition of WT PI3Kα (hyperglycemia) and other PI3K isoforms limits the tolerability, dosing and efficacy of the orthosteric inhibitor, alpelisib, the only approved solid tumor PI3K inhibitor...The primary endpoints are MTD/RP2D and AE profile for single agent and combination; key secondary endpoints are PI3KCA genotype in blood and tumor, PK, biomarkers, and overall response rate. US enrollment began December 2021 and ex-USA startup is underway."

Clinical • Combination therapy • P1 data • Breast Cancer • Cervical Cancer • Diabetes • Head and Neck Cancer • HER2 Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • HER-2 • PIK3CA

Relay Therapeutics Discloses Anticipated Registrational Path for RLY-4008 in Cholangiocarcinoma and Growing Breast Cancer Franchise at Virtual Analyst and Investor Event (GlobeNewswire) - "Relay Therapeutics today disclosed three new programs from a growing breast cancer franchise including a selective CDK2 inhibitor, a rationally designed ERα degrader, and a chemically distinct pan-mutant selective PI3Kα inhibitor (RLY-5836)....Relay Therapeutics progressed from first compound synthesized to an advanced CDK2 lead compound with robust selectivity over other CDK family members in less than a year. This program is expected to enter the clinic in Q4 2023 or Q1 2024....The company expects to nominate an ERα degrader development candidate in 2023....RLY-5836 is expected to be ready to enter the clinic in 2023."

New trial • Pipeline update • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology