tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma - LARVOL DELTA

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 primary completion date: Sep 2024 ➔ Dec 2024

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

Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Fudan University | Initiation date: Jul 2024 ➔ Dec 2024

Metastases • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Fudan University

Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • NECTIN4 • TACSTD2

BCTOP-L-M05: SNF Platform Study of HR+/ HER2-advanced Breast Cancer (clinicaltrials.gov) - P2 | N=620 | Recruiting | Sponsor: Fudan University | N=140 ➔ 620

Enrollment change • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

SHR-A1921-201: Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=220 | Active, not recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting | N=120 ➔ 220

Combination therapy • Enrollment change • Enrollment closed • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SHR-A1921: A trophoblast cell-surface antigen 2 (TROP-2) targeted antibody-drug conjugate (ADC) for the treatment of advanced NSCLC (ESMO 2024) - P1 | "SHR-A1921 showed promising clinical activity and a manageable safety profile in heavily pretreated NSCLC pts. A phase 3 study of SHR-A1921 in pts with advanced non-squamous NSCLC have been planned. Table: 1310P Efficacy summary BOR, ORR, DCR and DoR were analyzed in treated pts evaluable for anti-tumor response."

IO biomarker • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

SHR-A1921 in platinum-resistant ovarian cancer (PROC): data from a first-in-human (FIH) phase I study (ESMO 2024) - P1 | "Most pts had received prior bevacizumab (69.6%) and PARP inhibitors (58.7%). SHR-A1921 demonstrated promising efficacy with a manageable safety profile in heavily pretreated pts with PROC. A pivotal phase 3 study is currently in preparation."

P1 data • Oncology • Ovarian Cancer • Solid Tumor • TACSTD2

SHR-A1921…will be presented in oral presentations [Google translation] (Xinhua News Network) - P1 | N=156 | NCT05154604 | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | "A total of 46 patients with platinum-resistant ovarian cancer were included in this study. Among the 43 evaluable patients, the objective response rate (ORR) was 48.8% (21/43; 95% CI: 33.3-64.5), and the disease control rate (DCR) was 97.7% (42/43; 95% CI: 87.7-99.9). The median duration of response (DoR) was 6.4 months (95% CI: 4.7-not reached). The median progression-free survival (PFS) was 7.2 months (95% CI: 4.4-11.1). The median overall survival (OS) was not reached, and the 6-month OS rate was 91.9% (95% CI: 76.9-97.3)."

P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

SHR-A1921, A TROP-2 Targeted Antibody-Drug Conjugate (ADC), In Patients (pts) with Advanced Small-Cell Lung Cancer (SCLC) (IASLC-WCLC 2024) - P1 | "No TRAEs led to treatment discontinuation or death. Conclusions : SHR-A1921 showed promising clinical efficacy and a manageable safety profile in pts with heavily pretreated extensive-stage SCLC, even with low TROP-2 expression."

Clinical • IO biomarker • Metastases • Anemia • Dental Disorders • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Stomatitis • TACSTD2

A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=70 | Enrolling by invitation | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Combination therapy • Enrollment open • Metastases • Oncology • Solid Tumor • KRAS

OA04.05: SHR-A1921,A TROP-2 Targeted Antibody-Drug Conjugate(ADC),In Patients(pts) with Advanced Small-Cell Lung Cancer (SCLC) [Google translation] (Jiangsu Hengrui Press Release) - P1 | N=156 | NCT05154604 | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | "As of February 19, 2024, a total of 17 patients were enrolled, of whom 6 (35.3%) were still receiving treatment. At the time of study enrollment, 52.9% of patients had received ≥2 lines of prior treatment. 64.7% of patients had been treated with PD-1/PD-L1 antibodies, and 11.8% of patients had been treated with DNA topoisomerase I inhibitors. TROP-2 expression was detectable in 16 patients, all at low levels, with H scores of 0-50. The median follow-up time was 5.3 months (range: 1.3-9.4). Among the 15 patients who were evaluable for tumor response, the objective response rate (ORR) was 33.3% (95% CI: 15.2-58.3), the disease control rate (DCR) was 66.7% (95% CI: 41.7-84.8), and the median duration of response (DoR) was 4.4 months (95% CI: 2.3-NR)."

P1 data • Small Cell Lung Cancer

2024 WCLC Outlook | Hengrui Medicine’s 9 innovative drugs and 11 lung cancer research projects will be unveiled on the international stage [Google translation] (Jiangsu Hengrui Press Release) - "This year, Hengrui Medicine had 11 research results of 9 innovative drugs shortlisted for the conference, of which 3 studies were selected for oral reports (Oral) and 8 studies were accepted as posters...The 9 innovative drugs include...5 unmarketed products: TROP-2 antibody-drug conjugate SHR-A1921, anti-PD-L1/TGF-βRII dual antibody SHR-1701, IL-15 fusion protein SHR-1501, KRASG12D inhibitor HRS-4642, and multi-target receptor tyrosine kinase inhibitor famitinib."

Clinical data • Lung Cancer • Oncology • Small Cell Lung Cancer • 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 | Phase classification: P1/2 ➔ P2

Phase classification • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

SHR-A1921-303: SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P3 | N=440 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Ovarian Cancer • Solid Tumor

Hengrui Medicine: Subsidiary’s SHR-A1921 for injection received drug clinical trial approval notice [Google translation] (Sina Corp) - "Hengrui Medicine announced on July 29 that its subsidiary Suzhou Shengdia Biopharmaceutical co, Ltd. received the 'Drug Clinical Trial Approval Notice' for SHR-A1921 for injection from the National Medical Products Administration, approving the product to conduct clinical trials in combination with ametinib or bevacizumab and carboplatin/cisplatin for the treatment of advanced solid tumors."

New trial • Oncology • Solid Tumor

SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line Treatment (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Metastases • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=156 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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

A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Atridia Pty Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Apr 2024 | Trial primary completion date: Oct 2023 ➔ Apr 2024

Metastases • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Fudan University

Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Henan Cancer Hospital

Metastases • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase II umbrella clinical trial of advanced salivary gland cancer based on molecular typing. (ASCO 2024) - P2 | "Pts with HER2 mutation/amplification or HER2 overexpression (IHC 3+ or IHC 2+/ISH+) will be assigned to arm 1 and receive SHR-A1811(anti-HER2) 4...IHC AR+ pts will be assigned to arm 2 and will receive rezvilutamide 240mg p. o. qd plus leuprolide 3...Pts with HER2 negative and AR negative will be assigned to arm 3 to receive SHR-A1921(anti-TROP2) 3... This molecular subtype-guided precision therapy for advanced salivary gland cancer showed promising results with acceptable toxicity. Clinical trial information: NCT05924256."

Clinical • Metastases • P2 data • Dental Disorders • Oncology • Salivary Gland Cancer • Stomatitis • AR • NTRK

Hengrui Medicine (600276.SH): Clinical trial applications for three drugs from its subsidiary were approved [Google translation] (Sina Corp) - "According to the Zhitong Finance APP...issued an announcement that its subsidiaries Shanghai Hengrui Medicine Co., Ltd. and Suzhou Shengdia , Ltd. received the 'Drug Clinical Trial Approval Notice' approved by the National Medical Products Administration for the issuance of SHR-9839 for injection, SHR-A1921 for injection and SHR-A2009 for injection, and will conduct clinical trials in the near future."

New trial • Oncology • Solid Tumor

Jiangsu Hengrui Medicine : Hengrui Pharma Announces Positive Data of Two ADC Programs at the AACR Annual Meeting 2023 (Market Screener) - "Jiangsu Hengrui Pharmaceuticals...announced that there will be five poster presentations showcased at the 2023 American Association for Cancer Research (AACR) Annual Meeting....These posters will highlight:...(i) An optimized design and well-balanced profile between efficacy and safety of SHR-A1921, a novel TROP-2 ADC; and (ii) Clinical data of SHR-A1921 in phase 1 study for patients with advanced solid tumors."

Clinical • P1 data • Oncology • Solid Tumor

Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC (clinicaltrials.gov) - P1/2 | N=124 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Hengrui Pharmaceutical’s new ADC drug SHR-A1921 for injection is planned to be included in the breakthrough therapy variety! For the treatment of platinum-resistant ovarian cancer! [Google translation] (360doc) - P1 | N=156 | NCT05154604 | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | "On May 21, 2024, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration announced that SHR-A1921 for injection...is planned to be included in the breakthrough therapy category. The proposed indications this time are: for the treatment of patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer...At the data cut-off, 10 patients...achieved partial response (PR)...Dose-limiting toxicities were reported in four patients, all grade 3 stomatitis...There were 12 cases (31.6%) of grade 3 TRAEs ≥; Of these, stomatitis was the most common (n=7, 18.4%), and all other events were reported in ≤2 patients. No patient discontinued study treatment due to TRAEs."

Breakthrough therapy • P1 data • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor