SHR-A2102 / Jiangsu Hengrui Pharma - LARVOL DELTA

Nectin-4 targeted ADC, SHR-A2102, in patients with advanced or metastatic urothelial carcinoma: A phase 1 study. (ASCO-GU 2025) - P1 | "SHR-A2102 showed promising anti-tumor activity in pts with advanced or metastatic urothelial carcinoma, even after ADC therapy, along with manageable safety profile. Efficacy summary."

Clinical • Metastases • P1 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

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 Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov) - P3 | N=462 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4 • PD-L1

A Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=398 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • Cervical Cancer • Oncology • Solid Tumor

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 Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov) - P3 | N=462 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4 • PD-L1

Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting | N=120 ➔ 160

Enrollment change • Enrollment open • Oncology • Pancreatic Cancer • Solid Tumor

SHR-A2102-212: A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules. (PubMed, Front Mol Med) - "Enfortumab vedotin is an NECTIN4-targeting antibody-drug conjugate that is approved for the treatment of urothelial cancer, whereas other ADCs or derivatives that target NECTIN4, such as bulumtatug fuvedotin, SHR-A2102 and zelenectide pevedotin, are being studied in randomized phase III clinical trials. In contrast, arcotatug tavatecan, garetatug rezetecan, sonesitatug vedotin and tecotabart vedotin are anti-CLDN18.2 ADCs in phase III clinical trials for the treatment of CLDN18.2-positive gastric or gastroesophageal junction adenocarcinomas, and raludotatug deruxtecan is an anti-CDH6 ADC in a phase II/III clinical trial for the treatment of platinum-resistant ovarian cancer. ADCs that target cell-cell adhesion molecules are a rapidly emerging class of cancer therapeutics, and bispecific ADCs and longitudinal companion diagnostics are emerging to further improve the clinical benefits of conventional ADCs."

Journal • Review • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer • CDH17 • CDH6 • CLDN18 • CLDN6

Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Hengrui Medicine's independently developed Nectin-4 ADC innovative drug SHR-A2102 has been approved for clinical trials in combination with head and neck squamous cell carcinoma (Jiangsu Hengrui Press Release) - "The notice approved the conduct of a multicenter, open-label Phase Ib/II clinical study of SHR-A2102 for injection combined with Adebelimumab Injection with or without other anti-tumor treatments in subjects with recurrent/metastatic head and neck squamous cell carcinoma."

New P1/2 trial • Squamous Cell Carcinoma of Head and Neck

A study on the treatment of high-risk non-muscle-invasive bladder cancer with antibody-drug conjugate intravesical perfusion (ChiCTR) - P1/2 | N=42 | Not yet recruiting | Sponsor: Shanghai General Hospital; Shanghai General Hospital

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • NECTIN4

Renaissance: Reverse Triple Negative Immune Resistant Breast Cancer (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Fudan University | N=30 ➔ 70 | Trial completion date: Mar 2023 ➔ Mar 2027 | Trial primary completion date: Dec 2022 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer (clinicaltrials.gov) - P1/2 | N=96 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P1/2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

SHR-A2102-I-102: Phase I Study of SHR-A2102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=395 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Recruiting

Enrollment open • Solid Tumor

Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316) (clinicaltrials.gov) - P2/3 | N=840 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Study of SHR-A2102 Combined Other Antitumor Drugs in Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • Oncology • Solid Tumor

SHR-A2102 Combined With Adebrelimab as Neoadjuvant Therapy for Early Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=52 | Not yet recruiting | Sponsor: Henan Cancer Hospital | Initiation date: Mar 2025 ➔ Jun 2025

Trial initiation date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Phase 1 trial of SHR-A2102, a nectin-4–directed antibody drug conjugate (ADC), in advanced solid tumors. (ASCO 2025) - P1 | "SHR-A2102 demonstrated a manageable safety profile and promising activity across a variety of pretreated advanced solid tumors. Multiple trials are ongoing to further assess SHR-A2102 both as monotherapy and in combination therapy for solid tumors. Efficacy in selected tumor types (efficacy evaluable set).*Include responses to be confirmed."

Metastases • P1 data • Anemia • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Solid Tumor • NECTIN4

Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=32 | Not yet recruiting | Sponsor: Henan Cancer Hospital

New P1/2 trial • Solid Tumor

A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

An exploratory trial of SHR-A2102 in combination with Adebrelimab for the treatment of unresectable stage III non-small cell lung cancer (ChiCTR) - P2 | N=20 | Not yet recruiting | Sponsor: Shanghai Chest Hospital; Shanghai Chest Hospital

New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Hengrui Medicine's independently developed Nectin-4 ADC innovative drug SHR-A2102 has been approved for clinical trials in combination with the treatment of advanced solid tumors [Google tranlsation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Medicine's subsidiaries Suzhou Shengdia Biotechnology Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd. received the 'Drug Clinical Trial Approval Notice' for SHR-A2102 for injection, Adebelimumab Injection, and Bevacizumab Injection approved and issued by the National Medical Products Administration, approving a multicenter, open Phase II clinical study on the safety, tolerability and efficacy of SHR-A2102 for injection combined with other anti-tumor treatments in subjects with advanced solid tumors....'This study will explore the effectiveness and safety of multiple combined anti-tumor therapies in treating patients with advanced solid tumors'...."

Trial status • Solid Tumor