ruzaltatug rezetecan (SHR-A2009) / Jiangsu Hengrui Pharma - LARVOL DELTA

A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov) - P3 | N=576 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SHR-A2009-I-102: The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Apr 2024 | Trial primary completion date: Jun 2025 ➔ Apr 2024

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

A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • 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

A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Metastases • New P3 trial • Lung Cancer • Non Small Cell Lung 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

CAP 02: A Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=147 | Recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University | Trial completion date: Dec 2024 ➔ Dec 2025

Metastases • Trial completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma

Phase I study of SHR-A2009, a HER3-targeted ADC, in pretreated EGFR-mutated NSCLC (ESMO 2024) - P1 | "SHR-A2009 showed encouraging anti-tumor activity and a tolerable safety profile in pts with EGFR-mutated NSCLC progressing after EGFR-TKI. Further investigations are warranted."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • ERBB3

ADC drug SHR-A2009 + adebelimumab + ametinib recruits patients with EGFR mutation lung cancer [Google translation] (Sohu.com) - "SHR-A2009 for injection is an antibody-drug conjugate (ADC) targeting HER3 independently developed by the company....SHR-A2009 for injection combined with anti-tumor therapy (Phase Ib/II)."

Trial status • 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

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

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

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 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

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

Heavy! Hengrui Pharmaceutical's HER3 ADC innovative drug SHR-A2009 has obtained Fast Track Designation from the US FDA [Google translation] (Jiangsu Hengrui Press Release) - "On January 2024, 1, Hengrui Pharmaceutical announced that the company's self-developed HER1 antibody-conjugate (ADC) innovative drug SHR-A3 for injection has been granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA). For the treatment of metastatic non-small cell lung cancer (NSCLC) with EGFR mutations that have progressed after disease progression with third-generation EGFR tyrosine kinase inhibitors and platinum-based chemotherapy, this qualification will help accelerate the clinical trial and marketing registration progress."

Fast track designation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

2023 ESMO Oral Report｜Hengrui Pharmaceuticals’ ADC innovative drug SHR-A2009 phase I study results for the treatment of advanced solid tumors announced [Google translation] (Hithink RoyalFlush Information Network) - P1 | N=132 | NCT05114759 | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | "At the 2023 European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, Spain, the latest high-quality research data were released in a special oral report session, where global experts shared their views and had in-depth discussions. On October 23, the Phase I study of Hengrui Pharmaceutical's innovative drug, the HER3-targeted ADC drug SHR-A2009, for the treatment of advanced solid tumors was unveiled during the Mini Oral report session of the conference...No dose-limiting toxicities (DLT) were observed at doses up to 10.5 mg/kg; doses may be increased....Among evaluable patients, the objective response rate (ORR) of all patients (all tumor types) was 25.0% (9/36; 95%CI, 12.1-42.2), and the ORR of NSCLC patients was 30.0% (9/30; 95%CI , 14.7-49.4); the median duration of response (DoR) of patients in both groups was 7.0 months (range 2.8-8.5)."

P1 data • Oncology • Solid Tumor

Phase I study of SHR-A2009, a HER3-targeted ADC, in advanced solid tumors (ESMO 2023) - P1 | "Conclusions SHR-A2009 showed a tolerable safety profile and encouraging anti-tumor activity in pts with heavily pretreated advanced solid tumors. The trial is ongoing to assess SHR-A2009 at higher doses and in selected cancer types (NSCLC and other solid tumors)."

Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ERBB3

A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=270 | 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

2023 ESMO Preview︱Hengrui Medicine’s 35 research results on 13 innovative anti-tumor drugs will appear on the international stage [Google translation] (Jiangsu Hengrui Press Release) - "The 2023 European Society for Medical Oncology (ESMO) Congress will be held in Madrid, Spain, from October 20 to 24 (Central European Summer Time CEST)...Hengrui Medicine has a total of 35 research results of 13 innovative anti-tumor drugs shortlisted, of which 2 were selected as Proffered Papers.) report, 5 studies were selected as short oral (Mini Oral) reports, and 28 studies were accepted as poster reports, covering more than ten fields such as digestive tract tumors, breast cancer, cervical cancer, pancreatic cancer, lung cancer, melanoma, sarcoma, and cholangiocarcinoma...A total of 4 studies related to SHR-1701, SHR-A2009, SHR-A1811, and HRS-4642....A total of 11 studies related to camrelizumab, apatinib, SHR-A1811, and SHR-1701."

Clinical data • Colorectal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Melanoma • Oncology • Solid Tumor • HER-2 • KRAS

The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting | N=172 ➔ 19

Enrollment change • Enrollment closed • Metastases • Oncology • Solid Tumor

HER3 ADC combined with PD-L1! Hengrui Medicine’s new combination therapy program has been approved for clinical trials [Google translation] (Chengdu Bopu Yunda Technology) - "...Hengrui Medicine announced that the NMPA has approved the issuance of the PD-L1 monoclonal antibody adelbelimab HER3 ADC injection SHR-A2009 adelbelimab combined with amitinib or SHR-A2009 with or without Chemotherapy is used in patients with advanced solid tumors ."

New trial • Oncology • Solid Tumor

The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=172 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=132 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=172 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P1 trial • Oncology • Solid Tumor