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

A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov) - P3 | N=498 | Active, not recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SHR-A2009, a HER3-targeted ADC, plus aumolertinib (A) as 1L or =2L treatment for EGFR-mutated (EGFRm) NSCLC: A phase Ib/II study (ELCC 2026) - P1/2, P3 | "Legal entity responsible for the study Jiangsu Hengrui Pharmaceuticals Co.Ltd. Funding Jiangsu Hengrui Pharmaceuticals Co.Ltd."

ADC • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • ERBB3

SHR-A2009, a HER3-targeted ADC, in advanced solid tumors: Updates from a phase I study (ELCC 2026) - P1, P3 | "Based on balanced efficacy and safety, 8.0 mg/kg was selected as RP3D for SHR-A2009 monotherapy. A randomized phase III trial (NCT06671379) comparing SHR-A2009 with PBC is ongoing in pts with EGFR-mutated NSCLC progressing after EGFR-TKI."

ADC • First-in-human • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ERBB3

SHR-A2009, a HER3-targeted ADC, plus bevacizumab (Bev) for pretreated EGFR-mutated non-squamous (EGFRm nsq) NSCLC: A phase Ib/II study (ELCC 2026) - P1/2 | "Table: 23P Efficacy outcomes SHR-A2009 8.0 mg/kg + Bev 7.5 mg/kg (n=30) SHR-A2009 8.0 mg/kg + Bev 15 mg/kg (n=31) All SHR-A2009 8.0 mg/kg + Bev (n=61) Confirmed ORR (n/N; 95% CI), % 56.7 (17/30; 37.4–74.5) 61.3 (19/31; 42.2–78.2) 59.0 (36/61; 45.7–71.4) DCR (n/N; 95% CI), % 90.0 (27/30; 73.5–97.9) 93.5 (29/31; 78.6–99.2) 91.8 (56/61; 81.9–97.3) Median DoR (95% CI), mo 10.4 (4.5–NR) 14.7 (12.5–NR) 14.7 (9.5–NR) Ongoing response, % (n/N) 52.9 (9/17) 78.9 (15/19) 66.7 (24/36) PFS Event, n (%) 14 (46.7) 10 (32.3) 24 (39.3) Median (95% CI), mo 11.8 (8.5–NR) 10.9 (8.5–NR) 11.8 (10.8–NR) Median follow-up (range), mo 12.9 (1.1–18.7) 7.9 (2.2–17.4) 10.9 (1.1–18.7) DCR, disease control rate; NR, not reached; ORR, objective response rate; PFS, progression-free survival. Conclusions SHR-A2009 + Bev demonstrated manageable safety with encouraging activity in EGFRm nsqNSCLC progressing after EGFR-TKI therapy."

ADC • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • ERBB3

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

A Phase Ib Study of HS-10504 Combined Therapy in NSCLC (clinicaltrials.gov) - P1 | N=400 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

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

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 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

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

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

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