HRS8807 / Jiangsu Hengrui Pharma - LARVOL DELTA

A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=90 ➔ 46 | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Enrollment change • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Hengrui Medicine’s Class 1 new drug HRS8807 has been clinically approved for the combined treatment of ER-positive and HER2-negative breast cancer [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Pharmaceuticals and its subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd. received the 'Drug Clinical Trial Approval Notice' approved and issued by the National Medical Products Administration, which approved the company to conduct a study of HRS8807 combined with dalpiciclib in ER-positive, An open-label, multicenter phase I clinical study of safety, tolerability and pharmacokinetics in patients with HER2-negative metastatic or locally advanced breast cancer."

New P1 trial • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer

Phase I study of HRS8807, an oral selective ER covalent antagonist (SERCA), in ER+/HER2- locally advanced (LA) or metastatic (M) breast cancer (BC) (ESMO 2023) - P1 | "3 pts achieved PR (1 at 75 mg and 2 at 150 mg; in which 2 had prior SERD [fulvestrant] and all had prior CDK4/6i in the M setting; treatment duration was 8.4, 8.6+, and 7.0+ mo). 18F-FES PET-CT SUVmax decreased significantly after treatment. Conclusions HRS8807 was well-tolerated and showed early signs of robust antitumor activity, favorable PK properties (both parent and active metabolite), and high ER occupancy in pretreated ER+/HER2- LA/M BC."

Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

2023 ESMO Preview︱Hengrui Medicine’s 35 research results on 13 innovative anti-tumor drugs will appear on the international stage [Google translation] (Jiangsu Hengrui Press Release) - "A total of 2 studies related to fluzoparib and aderbelimab (SHR-1316)...A total of 9 studies related to pyrotinib, camrelizumab, apatinib, famitinib, and HRS8807....1 study related to camrelizumab combined with famitinib."

Clinical data • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Estrogen Receptor Positive Breast Cancer • Gastrointestinal Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer