SHR-1826 / Jiangsu Hengrui Pharma - LARVOL DELTA

2025 ASCO Oral Report | Hengrui c-MET ADC Innovative Drug SHR-1826 Phase I Study Results for the Treatment of Advanced Solid Tumors Announced (Jiangsu Hengrui Press Release) - P1 | N=240 | NCT06094556 | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | "Preliminary results showed that SHR-1826 has controllable safety in patients with advanced solid tumors and exhibits significant anti-tumor activity in patients with non-small cell lung cancer (NSCLC), and is expected to provide a new treatment option for patients with MET....A total of 116 subjects were included in the study, including 72 NSCLC subjects, and 44% of the subjects had received ≥ 3 lines of systemic anti-tumor therapy. Among 58 evaluable NSCLC patients, the objective response rate (ORR) reached 39.7%, the disease control rate (DCR) reached 94.8%, and tumor remission occurred at 4 mg/kg, 5 mg/kg, and 6 mg/kg. The efficacy covered patients with different c-MET expression levels. And the efficacy benefit can be observed in NSCLC patients who have used or not used EGFR-TKI before."

P1 data • Non Small Cell Lung Cancer • Solid Tumor

Phase 1 study of SHR-1826, a c-MET–directed antibody-drug-conjugate (ADC), in advanced solid tumors. (ASCO 2025) - P1 | "SHR-1826 demonstrated a manageable safety profile in pts with heavily pretreated advanced solid tumors. Promising anti-cancer activity was observed in MET-altered NSCLC, warranting further investigation in this population. Efficacy in pts with NSCLC."

Metastases • P1 data • Anemia • Febrile Neutropenia • Interstitial Lung Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR • MET

A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in the Treatment of Advanced Hepatocellular Cancer (clinicaltrials.gov) - P2 | N=53 | Not yet recruiting | Sponsor: Shanghai Zhongshan Hospital

Monotherapy • New P2 trial • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC (clinicaltrials.gov) - P1/2 | N=400 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Oncology • Solid Tumor

A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors (clinicaltrials.gov) - P1/2 | N=876 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC (clinicaltrials.gov) - P1/2 | N=400 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors (clinicaltrials.gov) - P1/2 | N=876 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Combination therapy • New P1/2 trial • Oncology • Solid Tumor

Hengrui Medicine’s innovative drug SHR-1826 for injection in combination with advanced solid tumors is approved for clinical trials [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Medicine's subsidiaries Shanghai Shengdi Pharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd. and Suzhou Shengdia Biotechnology Co., Ltd. received the 'Notice of Approval for Drug Clinical Trials' approved and issued by the National Medical Products Administration, approving the company to conduct a multicenter, open Phase IB/II clinical study on the safety, tolerability and efficacy of SHR-1826 for injection, HRS-4642 injection, adebelimumab injection, SHR-9839 for injection, SHR-8068 injection and bevacizumab injection in subjects with advanced solid tumors."

New P1/2 trial • Solid Tumor

An Open Phase I Clinical Trial of SHR-1826 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=240 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

An Open Phase I Clinical Trial of SHR-1826 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=240 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor