QLS1304 / Qilu Pharma - LARVOL DELTA

A phase 1b/2 study of QLS1304, a novel, highly potent, and selective dual inhibitor of KAT6A/6B, plus endocrine therapy (ET) in patients (pts) with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2−) breast cancer (BC). (ASCO 2026) - P1/2 | "The primary endpoints are safety, tolerability, and RP2D of QLS1304 combined with fulvestrant/QLC1401...In Cohort 2C (QLS1304 + CDK4/6i + letrozole), pts with LA/M ER+/HER2- BC with no prior therapy will be enrolled...The primary endpoint of phase 2 is ORR per RECIST v1.1. Patient enrollment is currently ongoing."

Clinical • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • KAT6A

First-in-human phase Ia trial of QLS1304, a novel, highly potent, selective dual lysine acetyltransferase 6A/6B (KAT6A/6B) inhibitor, in patients (pts) with advanced solid tumor (ESMO-BC 2026) - P1, P1/2 | "QLS1304 monotherapy showed an acceptable safety profile and promising anti-tumor activity in metastatic ER+/HER2- BC. The study to evaluate QLS1304 combined with ET ± CDK4/6i in ER+/HER2- BC is ongoing (NCT07235176)."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • KAT6A

QLS1304, a highly potent and selective KAT6A/B inhibitor treating ER+HER2- breast cancer (AACR 2025) - "Collectively, QLS1304 appears to be a promising candidate for the treatment of ER+HER2- breast cancer given its efficacy in both SoC-sensitive and SoC-resistant models. Moving it forward into clinical trials is warranted both as single agent and combining with other therapies."

Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • KAT6A • KAT6B • KAT8

Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=300 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=180 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor