SHR-A2102 / Jiangsu Hengrui Pharma - LARVOL DELTA

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

A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Oncology • Solid Tumor • Urothelial Cancer

Hengrui Medicine independently developed the innovative Nectin-4 ADC drug SHR-A2102 for the treatment of advanced solid tumors and received clinical approval [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Pharmaceutical’s subsidiaries Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai Shengdi Pharmaceutical Co., Ltd., Suzhou Shengdia Biopharmaceutical Co., Ltd. and Chengdu Shengdi Pharmaceutical Co., Ltd. received approval and issuance from the National Medical Products Administration regarding SHR for injection. - 'Drug Clinical Trial Approval Notice' for A2102, adebrelimab injection, SHR-8068 injection and abiraterone acetate tablets (II), approving the conduct of SHR-A2102 with or without abiraterone acetate tablets A clinical study of SHR-8068 with or without standard therapy in advanced solid tumors....This study will explore the effectiveness and safety of various anti-tumor therapies in treating patients with advanced solid tumors..."

New trial • Solid Tumor

A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=124 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Hengrui initiates Phase II clinical study of Nectin-4 ADC monotherapy for advanced gynecological tumors [Google translation] (bydrug.pharmcube.com) - "On October 21, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Hengrui has launched a Phase II clinical study of SHR-A2102 injection as a monotherapy for the treatment of gynecological malignancies...This study is an open, single-arm Phase II clinical study. The primary objective is to evaluate the effectiveness of SHR-A2102 in the treatment of advanced gynecological malignancies. The secondary objective is to evaluate the safety, tolerability, PK characteristics and immunogenicity of the drug."

Trial status • Gynecologic Cancers • Oncology • Solid Tumor

A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma (clinicaltrials.gov) - P1/2 | N=90 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Oncology • Solid Tumor • Urothelial Cancer

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