SHR-1316

DRUG16 trials

Sponsors

Atridia Pty Ltd., Jiangsu HengRui Medicine Co., Ltd., Fudan University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanghai Shengdi Pharmaceutical Co., Ltd

Conditions

Advanced Esophageal Squamous Cell CancerAdvanced MalignanciesAdvanced Solid TumorsBreast CancerBreast NeoplasmBreast TumorsEarly-stage Breast CancerExtensive-stage Small Cell Lung Cancer

Phase 1

A Trial to Evaluate Safety and Tolerability of SHR-1316 in Cancer Patients

CompletedNCT03133247

Atridia Pty Ltd.Advanced Solid Tumors

Start: 2017-06-01End: 2019-07-05Updated: 2022-07-12

Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors

Jiangsu HengRui Medicine Co., Ltd.Tumor

Start: 2018-03-01End: 2019-10-31Target: 134Updated: 2018-03-22

A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors

CompletedNCT03995472

Jiangsu HengRui Medicine Co., Ltd.Advanced Malignancies

Start: 2020-02-14End: 2023-01-12Updated: 2023-09-28

A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer

CompletedNCT04400188

Jiangsu HengRui Medicine Co., Ltd.Small Cell Lung Cancer

Start: 2020-06-11End: 2022-01-15Updated: 2025-06-29

Safety, Tolerability and Pharmacokinetics of the New Formulation SHR-1316 in Subjects With Advanced Tumors

Jiangsu HengRui Medicine Co., Ltd.Tumor

Start: 2021-08-10End: 2022-07-31Target: 15Updated: 2021-07-28

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC

RecruitingNCT06754930

Suzhou Suncadia Biopharmaceuticals Co., Ltd.Non-small Cell Lung Cancer (NSCLC)

Start: 2025-02-18End: 2027-12-31Target: 400Updated: 2025-04-17

Phase 2

SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer

Jiangsu HengRui Medicine Co., Ltd.Advanced Esophageal Squamous Cell Cancer

Start: 2018-11-30End: 2020-10-31Target: 30Updated: 2018-11-06

A Phase II Study of Triple-negative Breast Cancer Brain Metastases.

RecruitingNCT04303988

Fudan UniversityBreast Cancer

Start: 2020-03-30End: 2025-05-30Target: 35Updated: 2024-07-18

A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyLimited-stage Small Cell Lung Cancer, LS-SCLC

Start: 2020-11-27End: 2023-12-27Target: 60Updated: 2020-11-30

Reverse Triple Negative Immune Resistant Breast Cancer

RecruitingNCT05076682

Fudan UniversityTriple-negative Breast Cancer

Start: 2022-06-30End: 2027-03-31Target: 80Updated: 2025-12-03

Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02

RecruitingNCT05205200

Fudan UniversityBreast Cancer, Metastatic Cancer

Start: 2022-06-06End: 2026-08-01Target: 338Updated: 2024-02-08

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

RecruitingNCT05582499

Fudan UniversityBreast Cancer, Breast Neoplasm, Breast Tumors +7

Start: 2022-11-01End: 2028-09-30Target: 716Updated: 2025-08-22

A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer

Active, not recruitingNCT06237257

Shanghai Shengdi Pharmaceutical Co., LtdLocally Advanced Cervical Cancer

Start: 2024-03-20End: 2025-01-31Updated: 2024-12-24

A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

RecruitingNCT06778031

Suzhou Suncadia Biopharmaceuticals Co., Ltd.HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Start: 2025-02-26End: 2028-09-30Target: 54Updated: 2025-03-06

Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases

Not yet recruitingNCT07466927

Fudan UniversityHER2-negative Breast Cancer

Start: 2026-03-15End: 2029-01-15Target: 30Updated: 2026-03-12

Phase 3

Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

Jiangsu HengRui Medicine Co., Ltd.Extensive-stage Small Cell Lung Cancer

Start: 2018-12-30End: 2023-12-31Updated: 2022-04-18

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