notiretatug rezetecan (SHR-A2102) / Jiangsu Hengrui Pharma - LARVOL DELTA

SHR-A2102, a nectin-4 directed antibody-drug conjugate, in patients with pretreated advanced solid tumours: a multicentre, single-arm, phase 1 trial. (PubMed, Lancet Oncol) - P1 | "SHR-A2102 demonstrated a safety profile consistent with its topoisomerase I inhibitor payload and showed promising activity in patients with various advanced solid tumours who had previously received anti-cancer treatment. A range of active dose was identified in various tumour types. Several trials are ongoing to evaluate SHR-A2102, either as monotherapy or in combination, in advanced solid tumours."

Journal • P1 data • Breast Cancer • Cardiovascular • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Embolism • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • HER-2 • NECTIN4

SHR-A2102, a Nectin-4 ADC, Combined with EGFR-TKI in EGFR-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) After EGFR-TKI Failure: A Multicenter, Open-Label, Phase II Trial (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NECTIN4

SHR-A2102, a Nectin-4 targeted antibody-drug conjugate, combined with HRS-4642 in previously treated pancreatic ductal adenocarcinoma harboring KRAS G12D mutation. (ASCO 2026) - P2 | "SHR-A2102 combined with HRS-4642 showed a tolerable safety profile and promising preliminary anti-tumor activity in advanced PDAC harboring KRAS G12D mutation, irrespective of Nectin-4 expression."

ADC • Hematological Disorders • Oncology • Pancreatic Ductal Adenocarcinoma • KRAS • NECTIN4

SHR-A2102, a Nectin-4–directed antibody drug conjugate (ADC), in pretreated HR+/HER2- advanced breast cancer (aBC): results from a phase 1 study (ESMO 2026) - No abstract available

ADC • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Perioperative SHR-A2102, a novel nectin-4–targeted antibody-drug conjugate, in combination with adebrelimab for patients (pts) with muscle-invasive bladder cancer: Results from a phase 2/3 study. (ASCO 2026) - P2/3 | "Perioperative treatment with SHR-A2102 plus adebrelimab showed promising efficacy and was well tolerated in pts with MIBC. This combination holds potential benefit even for pts with renal impairment, suggesting its clinical applicability may extend beyond cisplatin-eligible populations. These results support further investigation for SHR-A2102 plus adebrelimab in this population."

ADC • Clinical • Combination therapy • P2/3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Renal Disease • Solid Tumor

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

SHR-A2102, a novel nectin-4-targeted antibody-drug conjugate, in patients with recurrent or metastatic cervical cancer: results from a phase 2 study (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor

SHR-A2102-201: A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Trial completion date: Jul 2027 ➔ Dec 2031 | Trial primary completion date: Jul 2027 ➔ Dec 2031

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

A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov) - P3 | N=453 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Trial completion date: Jun 2030 ➔ Oct 2030 | Trial primary completion date: Sep 2027 ➔ Jan 2028

Trial completion date • Trial primary completion date • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4 • PD-L1

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 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=210 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=96 ➔ 210 | Trial completion date: Mar 2028 ➔ Mar 2029 | Not yet recruiting ➔ Recruiting | Trial primary completion date: Mar 2026 ➔ Mar 2027

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

SHR-A2102 in combination with adebrelimab as first-line treatment in patients with locally advanced or metastatic squamous or non-squamous non-small cell lung cancer (NSCLC): Results from a phase 1b/2 study. (ASCO 2026) - P1/2 | "These results suggested the combination of SHR-A2102 and adebrelimab as the first-line therapy is a promising treatment strategy in patients with squamous or non-squamous NSCLC, supporting further investigation. Efficacy summary."

Clinical • Combination therapy • Metastases • P1/2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Novel ADC Combo Shows Efficacy in Phase 2 Bladder Cancer Data (Oncology News Central) - "Results from the phase 2 portion of a phase 2/3 study were reported at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and show that the SHR-A2102 combined with the PD-L1 inhibitor adebrelimab (AiRuiLi) and delivered in both the neoadjuvant and adjuvant settings, was associated with an objective response rate of 71.4% (95% confidence interval, 29.0%–96.3%) among patients with measurable target lesions....After a median follow-up of 4.7 months, three event-free-survival (EFS) events were reported. The median EFS had not been reached at the time of data cutoff in November 2025."

P2 data • Bladder Cancer

Hengrui Pharmaceuticals…announced that SHR-A2102 for injection, developed by its subsidiary Shanghai Hengrui, has been included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation of the National Medical Products Administration. (iis.aastocks.com) - "The proposed indication is for the treatment of recurrent or metastatic cervical cancer that has failed platinum-containing chemotherapy and PD-(L)1 inhibitor therapy."

Breakthrough therapy • Cervical Cancer

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

Enrollment open • Cervical 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 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