HRS-6209 / Jiangsu Hengrui Pharma - LARVOL DELTA

A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants (clinicaltrials.gov) - P1 | N=21 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Sep 2026 | Trial primary completion date: Jun 2026 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2028 ➔ Sep 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=528 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Aug 2026 ➔ Aug 2028 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Atridia Pty Ltd. | Not yet recruiting ➔ Recruiting

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

A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Breast Cancer • Oncology • Solid Tumor

Phase 1 study of HRS-6209, a highly selective CDK4 inhibitor, in patients with advanced solid tumors (AACR 2026) - "In HR+/HER2− breast cancer pts, the median prior lines of endocrine therapy and chemotherapy in the metastatic setting were 1.5 and 1.0, respectively; 32 (66.7%), 39 (81.3%), and 29 (60.4%) had received prior CDK4/6 inhibitor, aromatase inhibitor, and fulvestrant, respectively. HRS-6209 was well-tolerated, exhibiting favorable safety and PK profiles in patients with advanced solid tumors, and demonstrated promising anti-tumor activity in pretreated patients with HR+/HER2- breast cancer.Table 1. Key baseline characteristics and efficacy in patients with HR+/HER2- breast cancer* Defined as complete or partial response, or stable disease lasting ≥24 weeks."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

A Phase I Clinical Study of the Safety， Tolerability，Pharmacokinetics, and Initial Efficacy of HRS-6209 Monotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | N=90 ➔ 56

Enrollment change • Enrollment closed • Monotherapy • Oncology • Solid Tumor

A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=180 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

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

To Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects With HR-Positive/HER2-Negative Solid Tumor (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Atridia Pty Ltd.

New P1 trial • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Clinical Study of HRS-6209 in Combination With Letrozole in Patients With Breast Cancer (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

A Clinical Study of HRS-6209 in Combination With Letrozole in Patients With Breast Cancer (clinicaltrials.gov) - P1/2 | N=80 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

Hengrui Medicine’s innovative drug HRS-2189 tablets for combination therapy of advanced solid tumors approved for clinical trials [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Medicine...received the 'Notice of Approval for Drug Clinical Trial' approved and issued by the National Medical Products Administration, approving the company to conduct an open, multicenter Phase IB/II clinical study on the safety, tolerability, pharmacokinetics and preliminary efficacy of HRS-2189 combined with fulvestrant with or without HRS-6209, or with HRS-6209 and HRS-8080, or with HRS-6209 and HRS-1358, or with abiraterone acetate tablets (II) and prednisone tablets, or with HRS-5041, or with adebelimumab with or without SHR - 8068 with or without chemotherapy, or with adebelimumab and bevacizumab in subjects with advanced unresectable or metastatic solid tumors."

Trial status • Breast Cancer • Oncology • Solid Tumor

A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=300 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor

A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=528 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Breast Cancer • Oncology • Solid Tumor

A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=528 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor

Hengrui Medicine's three innovative cancer drugs were approved for clinical trials! Two of them are protein degraders [Google translation] (Sina Corp) - "Hengrui Medicine announced on the evening of July 26 that the company and its subsidiary Shandong Shengdi Pharmaceutical's HRS-1358 tablets, HRS-8080 tablets, and HRS-6209 capsules have received drug clinical trial approval notices issued by the China National Medical Products Administration (NMPA) and will conduct clinical trials in the near future. The approved clinical indications are: HRS-6209 combined with HRS-1358 or HRS-8080 or aromatase inhibitors or fulvestrant for the treatment of breast cancer."

New trial • Breast Cancer • Oncology • Solid Tumor

Announcementfrom Jiangsu Hengrui Pharmaceutical Co., Ltd. on Obtaining the Approval Notice for Drug Clinical Trials (Shanghai Securities News) - "Recently, Jiangsu Hengrui Pharmaceutical Co., Ltd...received the approval and issuance of the 'Drug Clinical Trial Approval Notice' for HRS-6209 tablets from the State Food and Drug Administration (hereinafter referred to as the 'NMPA'). Clinical trials will be carried out in the near future."

New trial • Oncology • Solid Tumor

A Phase I Clinical Study of the Safety， Tolerability，Pharmacokinetics, and Initial Efficacy of HRS-6209 Monotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor