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

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, 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

Clinical overview of trophoblast surface antigen 2 antibody-drug conjugates in non-small cell lung cancer. (PubMed, Cancer Treat Rev) - "There are 5 TROP2-directed ADCs currently under investigation for treatment of NSCLC: datopotamab deruxtecan, sacituzumab govitecan, sacituzumab tirumotecan, DB-1305, and SHR-A1921. TROP2 ADCs have shown antitumor responses with a manageable safety profile in patients with mNSCLC in several ongoing and completed trials. Additional studies are required to understand how these agents can be effectively integrated into the treatment paradigm for lung cancer, taking into consideration sequential use of multiple ADCs, resistance mechanisms, combination therapies, and use in special populations."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Trop2-directed antibody-drug conjugate shr-a1921 combined with pd-l1 inhibitor adebrelimab for patients with advanced triple negative breast cancer: results from a phase 2, multi-cohort, open-label, non-controlled trial (SABCS 2025) - P2 | "The combination of SHR-A1921 and adebrelimab demonstrated promising anti-tumor efficacy and manageable safety in pretreated TNBC pts regardless of PD-L1 status, warranting further investigations in this population. Our exploration of ADCs combined with adebrelimab in HER2-negative advanced breast cancer is still ongoing."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - P2 | N=88 | Active, not recruiting | Sponsor: Fudan University | Recruiting ➔ Active, not recruiting

Enrollment closed • Non-Adenoid Cystic Carcinoma • Oncology • Salivary Gland Cancer • AR • HER-2

SHR-A1921, a novel trophoblast cell-surface antigen 2 targeted antibody-drug conjugate, with or without adebrelimab in advanced triple-negative breast cancer (TNBC): Data from two open-label, multicenter clinical trials (ESMO 2025) - P1, P1/2 | "DCR, disease control rate; PFS, progression-free survival. Conclusions SHR-A1921 with or without adebrelimab showed favorable efficacy and safety profile in pts with advanced TNBC."

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

TROP-2-targeted antibody-drug conjugate SHR-A1921 for advanced or metastatic solid tumors: A first-in-human phase 1 study. (PubMed, Cancer Cell) - P1 | "No significant correlation was found between TROP-2 expression and treatment efficacy. In summary, SHR-A1921 exhibited promising antitumor activity and a manageable safety profile, with 3.0 mg/kg every 3 weeks selected for further clinical development."

First-in-human • Journal • P1 data • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Cervical Cancer • Dental Disorders • Hematological Disorders • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Stomatitis • Triple Negative Breast Cancer • TACSTD2

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 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

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

An Exploratory Clinical Study of TROP2 ADC SHR-A1921 Combined With Adebrelimab for Advanced NSCLC After Failure of First-line Standard Therapy (IASLC-WCLC 2025) - P2 | "And the exploratory objective is to evaluate the dynamic change of biomarkers during treatment. Enrollment began on July 8, 2024, and the study is ongoing."

Clinical • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - P2 | N=88 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2026 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Oncology • Salivary Gland Cancer • AR • HER-2

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…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

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