SHR-A2102 / Jiangsu Hengrui Pharma - LARVOL DELTA

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

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

New P2 trial • Oncology • Solid Tumor

SHR-A2102-I-102: Phase I Study of SHR-A2102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=395 | Active, not recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=200 ➔ 395

Enrollment change • Enrollment closed • Oncology • 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 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P2/3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma (clinicaltrials.gov) - P3 | N=402 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • Urothelial Cancer

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

ASCO GU 2025: Nectin-4 Targeted ADC, SHR-A2102, in Patients With Advanced or Metastatic Urothelial Carcinoma: A Phase 1 Study (UroToday) - P1 | N=252 | NCT05735275 | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | "The 2025 GU ASCO annual meeting featured a session on the ABCs of antibody drug conjugates and a presentation by Dr. Bixia Tang discussing a phase 1 study assessing SHR-A2102, a nectin-4 targeted antibody drug conjugate, in patients with advanced or metastatic urothelial carcinoma....Confirmed objective response rate was 38.3% (95% CI 27.7–49.7) in all patients, and was 41.9% (95% CI 24.5–60.9) in the 6 mg/kg dose group and 50.0% (95% CI 31.9–68.1) in the 8 mg/kg dose group. The 6-month duration of response rate was 53.1% (95% CI 23.1–83.0) in all patients, and was 59.5% (95% CI 23.5–83.0) and 43.5% (95% CI 8.3–75.7) in the 6 and 8 mg/kg groups, respectively. The median progression free survival in the 6 mg/kg group was 5.8 months (95% CI 3.9-9.0) and in the 8 mg/kg group was 5.8 months (95% CI 3.4-8.2)."

P1 data • Urothelial Cancer

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

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

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. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Hengrui Nectin-4 ADC innovative drug SHR-A2102 urothelial carcinoma indication included in proposed breakthrough therapy announcement [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Medicine's subsidiary Shanghai Hengrui Medicine Co., Ltd.'s SHR-A2102 for injection as a single-agent treatment for locally advanced or metastatic urothelial carcinoma that has failed previous platinum-containing chemotherapy and PD-(L)1 inhibitor treatment was included in the list of proposed breakthrough therapies by the Center for Drug Evaluation of the National Medical Products Administration....In the SHR-A2102-I-101 study, SHR-A2102 for injection initially showed efficacy and tolerable safety in subjects with advanced UC after multiple lines of treatment. Specific data will be announced at a recent academic conference."

Breakthrough therapy • Urothelial Cancer

SHR-A2102-208: A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gynecologic Cancers • Oncology

A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma (clinicaltrials.gov) - P3 | N=402 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Metastases • New P3 trial • Oncology • Solid Tumor • Urothelial Cancer