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

Ruzaltatug rezetecan, a HER3-directed ADC, vs platinum-based chemotherapy (PBC) in EGFR-mutated advanced NSCLC progressing after EGFR-TKI: interim analyses (IA) from the phase 3 HERON-Lung01 trial (ESMO 2026) - No abstract available

ADC • Late-breaking abstract • Metastases • P3 data • P3 data: top line • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ERBB3

Anti-HER3 Antibody-Drug Conjugate (ADC) SHR-A2009 plus Adebrelimab in Immunotherapy-Treated Advanced Esophageal Squamous Cell Carcinoma (ESCC): Cohort D Results from the CAP 02 Study (ESMO 2026) - No abstract available

ADC • Metastases • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

SHR-A2009 plus adebrelimab (Adebre) with or without bevacizumab (Bev) for pretreated NSCLC: a phase 1b/2 study (ESMO 2026) - No abstract available

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

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

Hengrui’s HER3 ADC Ruzaltatug Rezetecan Wins China Breakthrough Therapy Designation – A New Option for EGFR‑Mutant NSCLC After TKI Failure (flcube.com)

Breakthrough therapy • Lung Non-Squamous Non-Small Cell Cancer

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

Hengrui HER3 ADC innovative drug injection ruzaltatug rezetecan for EGFR mutation for late stage non-small cell lung cancer market application accepted [Google translation] (Jiangsu Hengrui Press Release) - "The listing is based on a randomized, open-label, multi-center Phase III clinical trial evaluating the effectiveness and safety of ruzaltatug rezetecan (R&D code: SHR-A2009) in patients with advanced EGFR mutations or metastatic non-small cell lung cancer who have failed in EGFR TKI treatment."

China filing • Non Small Cell Lung Cancer

SHR-A2009-I-101: A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=176 | Active, not recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting | N=132 ➔ 176 | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • 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 | 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 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-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

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

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

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

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