SHR-1501 / Jiangsu Hengrui Pharma - LARVOL DELTA

IL-15RαFc superagonist SHR-1501 with or without bacille Calmette Guerin (BCG) for high-risk non-muscle invasive bladder cancer (NMIBC): A phase 1/2 study. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT05410730 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Hengrui Medicine's innovative drug SHR-1501 combined with Adebelimumab for bladder cancer approved for clinical trials [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Medicine's subsidiaries Shanghai Hengrui Medicine Co., Ltd. and Shanghai Shengdi Pharmaceutical Co., Ltd. received the 'Notice of Approval for Drug Clinical Trial' approved and issued by the National Medical Products Administration, approving the company to conduct clinical trials of SHR-1501 injection (bladder instillation) combined with adebelimumab injection (intravenous injection) for non-muscle-invasive bladder cancer."

New trial • Bladder Cancer

SHR-1501 Combined With SHR-2005 for High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt (clinicaltrials.gov) - P1/2 | N=58 | Not yet recruiting | Sponsor: Fudan University

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Novel IL-15 Superagonist SHR-1501 Promotes Immune Response in Lung Cancer via Modulating Tumor Microenvironment (IASLC-WCLC 2024) - "Conclusions : The novel IL-15 superagonist, SHR-1501, has a strong anti-tumor effects in lung cancer cell mouse models, and the combination of SHR-1501 with PD-1 mAb had shown a potent synergistic anti-tumor effect. The findings from this study can provide evidence and experimental basis to support further clinical trial."

Biomarker • Tumor microenvironment • Lung Cancer • Oncology • Solid Tumor • CD8 • KRAS

P1.02C.03: A novel IL-15 superagonist SHR-1501 promotes immune response in lung cancer by regulating the tumor microenvironment [Google translation] (Jiangsu Hengrui Press Release) - "The study found that in both mouse models, administration of SHR-1501 alone at a dose of 5/15 μg significantly inhibited tumor growth. Higher doses showed more effective anti-tumor effects without significant toxicity. We found that the infiltration of CD8+ T cells, effector CD8+ T lymphocytes, and natural killer (NK) cells in the tumor microenvironment was enhanced....Single-cell sequencing results also showed that SHR-1501 can regulate cell populations such as macrophages in the tumor microenvironment, leading to a shift to a more favorable anti-tumor immune response."

Preclinical • Lung Cancer

2024 WCLC Outlook | Hengrui Medicine’s 9 innovative drugs and 11 lung cancer research projects will be unveiled on the international stage [Google translation] (Jiangsu Hengrui Press Release) - "This year, Hengrui Medicine had 11 research results of 9 innovative drugs shortlisted for the conference, of which 3 studies were selected for oral reports (Oral) and 8 studies were accepted as posters...The 9 innovative drugs include...5 unmarketed products: TROP-2 antibody-drug conjugate SHR-A1921, anti-PD-L1/TGF-βRII dual antibody SHR-1701, IL-15 fusion protein SHR-1501, KRASG12D inhibitor HRS-4642, and multi-target receptor tyrosine kinase inhibitor famitinib."

Clinical data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Oncology • CD8

A Study of SHR-1501 in Patients With Advanced Tumors (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Unknown status ➔ Completed | N=48 ➔ 19

Enrollment change • Metastases • Trial completion • Oncology • CD8

A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • CD8

A Study of SHR-1501 Alone or in Combination With BCG in Subjects With NMIBC (clinicaltrials.gov) - P1/2 | N=129 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2022 ➔ Nov 2022

Combination therapy • Enrollment open • Trial initiation date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting | N=104 ➔ 14 | Trial completion date: Jun 2023 ➔ Dec 2022 | Trial primary completion date: Jun 2022 ➔ Sep 2022

Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • CD8

A Study of SHR-1501 Alone or in Combination With BCG in Subjects With NMIBC (clinicaltrials.gov) - P1/2 | N=129 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Combination therapy • New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Study of SHR-1501 in Patients With Advanced Tumors (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Trial completion date: Jul 2021 ➔ Dec 2021; Trial primary completion date: Jul 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Oncology

A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors (clinicaltrials.gov) - P1; N=104; Recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open

A Study of SHR-1501 in Patients With Advanced Tumors (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors (clinicaltrials.gov) - P1; N=104; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Trial completion date: Dec 2022 ➔ May 2023; Initiation date: Aug 2019 ➔ Jan 2020; Trial primary completion date: Dec 2021 ➔ May 2022

Clinical • Combination therapy • Trial completion date • Trial initiation date • Trial primary completion date

Hengrui combines PD-L1 mAb with IL-15 fusion protein in China clinical trial (GBI Health) - “China’s Jiangsu Hengrui Medicine Co., Ltd…announced clinical trial approval for its anti-programmed death ligand-1 (PD-L1) monoclonal antibody (mAb) SHR-1316 in combination with the interleukin (IL)-15 fusion protein SHR-1501 as a combination treatment for advanced malignant tumors.”

Clinical protocol

A Study of SHR-1501 in Patients With Advanced Tumors (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • New P1 trial