HRS-8080 / Jiangsu Hengrui Pharma - LARVOL DELTA

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 Study to Assess the Mass Balance of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects. (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Breast Cancer • Oncology • Solid Tumor

HRS-8080, an oral selective estrogen receptor degrader (SERD), in ER+/HER2− advanced breast cancer (aBC) with ESR1 mutations (ESR1m): Results from a first-in-human phase 1 trial. (ASCO 2026) - P1 | "HRS-8080 demonstrated a favorable safety and tolerability profile and encouraging antitumor activity in ESR1m ER+/HER2− aBC, supporting ongoing clinical development both as monotherapy and in combination regimens. Key baseline characteristics and efficacy in ESR1m subset.* Data cutoff, Dec. 18, 2025."

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

HRS-8080-102: A Clinical Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Breast Cancer • 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 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. (clinicaltrials.gov) - P3 | N=912 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2026 ➔ Mar 2026

Enrollment open • Trial initiation date • Breast Cancer • Oncology • Solid Tumor

A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer (clinicaltrials.gov) - P3 | N=4800 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • 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

A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. (clinicaltrials.gov) - P3 | N=912 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 trial • Breast Cancer • Oncology • Solid Tumor

A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Postmenopausal Women With High-Risk Early Breast Cancer (clinicaltrials.gov) - P3 | N=4800 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 trial • Breast Cancer • Oncology • Solid Tumor

A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Oncology • Solid Tumor

Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=146 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Oct 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Study to Assess the Mass Balance of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects. (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial • Breast Cancer • Oncology • Solid Tumor

A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor

A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial • Breast Cancer • Oncology • Solid Tumor

SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Henan Cancer Hospital

New P2 trial • Breast Cancer • Oncology • Solid Tumor

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 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 4 new cancer drugs approved for clinical trials, 3 of which are protein degraders [Google translation] (Sina Corp) - "On October 18, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Hengrui Medicine...has 4 new cancer drugs approved for multiple new clinical trial implied licenses. One of them is an anti-CTLA-4 monoclonal antibody new drug, and the other three are Class 1 new drugs for protein degradation therapy. These new drugs have been approved for clinical research on the treatment of malignant tumors with dual or triple drug combination therapy , which means that Hengrui Medicine has an important exploration direction in cancer treatment."

New trial • Oncology • Solid Tumor

Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=350 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • 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 Phase 1, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 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