IDE574 / Ideaya Biosci - LARVOL DELTA

A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: IDEAYA Biosciences | Phase classification: P1/2 ➔ P1

Monotherapy • Phase classification • Breast Cancer • Castration-Resistant Prostate Cancer • Colorectal Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • ER • HER-2

The KAT6/7 inhibitor IDE574 disrupts tumor lineage identity and drug tolerance to deliver robust antitumor activity in biomarker selected indications (AACR 2026) - "Consistent with this biology, IDE574 delivered deeper and durable antitumor activity in aggressive ER+ mBC PDX models including ESR1 mutant backgrounds reported to be resistant to the clinical KAT6 inhibitor even when combined with palbociclib and fulvestrant. Pan-cancer cell viability assessments and xenograft studies with IDE574 revealed indication opportunities in addition to mBC, including predictive biomarker-associated subsets of NSCLC and bowel cancer. These preclinical findings combined with favorable drug-like properties and non-clinical safety profile support evaluation of IDE574 in the clinic as a treatment option for patients with biomarker positive disease."

Biomarker • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD133 • CD24 • ER • FOXA1 • GATA3 • KAT6A • KAT6B • KAT8

A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: IDEAYA Biosciences

Monotherapy • New P1/2 trial • Breast Cancer • Castration-Resistant Prostate Cancer • Colorectal Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • ER • HER-2

IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE574, a Potential First-In Class Dual Inhibitor of KAT6/7 to Target Multiple Solid Tumor Indications, including Breast, Prostate, CRC, and Lung Cancer (PRNewswire) - "The company is planning to evaluate safety, efficacy and pharmacokinetics of IDE574 as a monotherapy in the Phase 1 dose escalation trial in solid tumor patients, including breast, prostate, colorectal, and lung cancer."

Trial status • Breast Cancer • Colorectal Cancer • Non Small Cell Lung Cancer • Prostate Cancer

IDEAYA Biosciences Announces Upcoming Presentations at AACR 2026 Highlighting Multiple Clinical Stage Pipeline Programs (PRNewswire) - "The presentations will highlight preclinical data from three potential first-in-class programs from IDEAYA's clinical stage pipeline: IDE034, a PTK7/B7H3 bi-specific topoisomerase-1 (TOP1) antibody-drug conjugate (ADC); IDE574, a potent dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7; and IDE892, an MTA-cooperative inhibitor of PRMT5."

Preclinical • Oncology

IDEAYA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update (PRNewswire) - "Nomination of a development candidate for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, expected in H2 '26 followed by IND submission to the U.S. FDA in H1 '27....IDE574 (KAT6/7)...targeting to initiate a Phase 1 dose escalation trial in patients with breast, lung, prostate and colorectal cancers Q1 '26."

IND • New P1 trial • Pipeline update • Breast Cancer • Colorectal Cancer • Lung Cancer • Prostate Cancer

2026 Corporate Objectives:...Next Generation Therapies (PRNewswire) - "IDE574 (KAT6/7): obtained clearance of an IND application with the U.S. FDA in January 2026; target to initiate Phase 1 dose escalation trial in Q1 '26."

IND • New P1 trial • Solid Tumor

IDEAYA Biosciences Announces IND Submission for IDE574, a Potential First-In-Class KAT6/7 Dual Inhibitor for Breast and Lung Cancers (PRNewswire) - "The company is targeting to begin a Phase 1 dose escalation trial of monotherapy IDE574 in the first quarter of 2026....IND-enabling studies support the potential clinical evaluation of IDE574 monotherapy in patients with hormone receptor-positive breast cancer, lung adenocarcinoma as well as additional opportunities associated with lineage addiction. IDEAYA is targeting to share data from its preclinical work with IDE574 at a medical conference in the first half of 2026."

IND • New P1 trial • Preclinical • Hormone Receptor Positive Breast Cancer • Lung Adenocarcinoma

In the fourth quarter IDEAYA submitted an IND for IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, and is on track to file an IND for IDE574, a potential first-in-class KAT6/7 dual inhibitor, by the end of the year. (PRNewswire)

IND • Solid Tumor

IDEAYA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides Business Update (PRNewswire) - "IDE892: a potential best-in-class MTA-cooperative PRMT5 inhibitor to enable wholly-owned combination with IDE397. IND filing targeted for mid-year 2025....IDE034: a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC with combination potential with IDE161. IND filing targeted for the second half of 2025. IDE574: a potential first-in-class KAT6/7 dual inhibitor development candidate with combination opportunities with multiple programs in the Company's pipeline. IND filing targeted for the second half of 2025."

IND • Oncology