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

Impact of bevacizumab on the efficacy of antibody–drug conjugates as later-line treatment of basal-like immune-suppressed triple-negative breast cancer. (ASCO 2026) - P2 | "In arm C, patients received either SHR-A1811 (anti-HER2 ADC, 4.8 mg/kg IV q3w) alone (C1) or with bevacizumab (15 mg/kg IV q3w) (C2). In arm D, patients received either SHR-A1921 (Trop2-targeted ADC, 3.0 mg/kg IV q3w) alone (D1) or with bevacizumab (7.5 mg/kg IV q3w) (D2)... This study provides preliminary evidence of synergy between bevacizumab and ADCs, supporting a promising new strategy—especially for basal-like, immune-suppressed TNBC. Phase III trials are ongoing to confirm the efficacy and safety of this combination. The efficacy table."

ADC • Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

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

Preliminary Efficacy and Safety of TROP2-ADC SHR-A1921 Plus Adebrelimab in Advanced Driver-Negative NSCLC After First-Line Standard Therapy (IASLC-WCLC 2026) - "Conclusions : Despite a low objective response rate, the combination of SHR-A1921 and adebrelimab showed promising antitumor activity in pretreated advanced driver-negative NSCLC with a median PFS of 6.9 months and median OS of 15.2 months. Enhanced benefit was observed in squamous NSCLC."

ADC • Clinical • Metastases • Dental Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Solid Tumor • Stomatitis • PD-1

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

Efficacy and Safety of Sequential HER3-ADC or Trop2-ADC Following Prior ADC Progression in NSCLC (IASLC-WCLC 2026) - "Those with prior Trop2-ADC treatment received SHR-A2009 (HER3-ADC, 8 mg/kg, IV, q3w); those with prior HER3-ADC treatment received SHR-A1921 (Trop2-ADC, 3 mg/kg, IV, q3w). However, durable clinical benefit was observed in a subset of patients with EGFR-mutant tumors, with both responders achieving PFS exceeding 9 months. These signals warrant further investigation to identify biomarkers that may predict benefit from sequential ADC therapy with similar payloads."

ADC • Clinical • Dental Disorders • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • Stomatitis • EGFR • ERBB3

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

BJGBYY-IIT-LCYJ-2024-008: Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=113 | Recruiting | Sponsor: Beijing GoBroad Hospital | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jul 2027 ➔ Mar 2027

Enrollment open • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • HER-2

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 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Trial completion date: Jun 2027 ➔ Dec 2029 | Trial primary completion date: Jun 2026 ➔ Jun 2029

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase II study of SHR-A1921, a TROP2-targeted antibody-drug conjugate, in patients with recurrent or metastatic salivary gland carcinoma. (PubMed, NPJ Precis Oncol) - P2 | "Trial registration: ClinicalTrials.gov, NCT05924256. Registered on June 29, 2023."

Journal • P2 data • Adenoid Cystic Carcinoma • Mucositis • Non-Adenoid Cystic Carcinoma • Oncology • Salivary Gland Cancer • Stomatitis • AR • HER-2 • TACSTD2

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 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SHR-A1921-205: 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=0 | Withdrawn | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=124 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - P2 | N=88 | Active, not recruiting | Sponsor: Fudan University | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial primary completion date • Non-Adenoid Cystic Carcinoma • Oncology • Salivary Gland Cancer • AR • HER-2

Preclinical activity of SHR-A1921, a novel antibody-drug conjugate targeting trophoblast cell-surface antigen2 (Trop-2) in prostate cancer. (PubMed, Front Pharmacol) - "SHR-A1921 is a promising Trop-2-targeted ADC that leverages innovative technology to deliver potent antitumor activity against Trop-2-expressing prostate cancer cells, with an acceptable safety profile observed in preclinical studies. These results highlight the promising clinical potential of SHR-A1921 as a therapeutic option for prostate cancer patients with Trop-2-positive tumors."

Journal • Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • TACSTD2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Fudan University | N=120 ➔ 160

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

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