MK-2750 / Merck (MSD), Sichuan Kelun Pharma - LARVOL DELTA

A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | N=30 ➔ 120 | Not yet recruiting ➔ Recruiting

Enrollment change • Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

A Study of SKB571 in Participants With Gastrointestinal Tumors (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

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

SKB571-II-02: A Phase II Study of SKB571 in Patients With Lung Cancer (clinicaltrials.gov) - P2 | N=295 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | N=190 ➔ 295

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

SKB571-Ⅱ-03: A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Study of SKB571 in Participants With Gastrointestinal Tumors (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

New P2 trial • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Sustained Value Release of ADCs Under Development with Tiered Advancement of Innovation Pipeline (The Manila Times) - "The company is planning to initiate the Phase 1/2 clinical study for SKB118 in China in the first half of 2026...SKB571/MK-2750 (novel bsADC): The Phase 2 clinical trial in China is ongoing; SKB518 (novel ADC with a potential FIC target): The Phase 2 clinical trials are ongoing in China; SKB500 (novel ADC): The Phase 2 study is ongoing in China."

New P1/2 trial • Platinum sensitive • Trial status • Cervical Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Non Small Cell Lung Cancer • Peritoneal Cancer • Small Cell Lung Cancer • Solid Tumor

SKB571-II-02: A Phase II Study of SKB571 in Patients With Lung Cancer (clinicaltrials.gov) - P2 | N=190 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

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

A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=138 | Recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase II Study of SKB571 in Patients With Lung Cancer (clinicaltrials.gov) - P2 | N=190 | Not yet recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

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

SKB571/MK-2750: (PRNewswire) - "A novel bsADC that primarily targets various solid tumors such as LC and CRC etc. being developed in collaboration with MSD. The Phase 2 clinical trial in China is to be initiated."

New P2 trial • Colorectal Cancer • Lung Cancer

A Phase 1 Study of SKB571 in Subjects with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=138 | Not yet recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

Kelun Biotech's new ADC drug SKB571 for the treatment of various solid tumors has obtained the CDE clinical trial approval notice [Google translation] (bydrug.pharmcube.com) - "On November 15, 2024, Sichuan Kelun Botai Biotechnology Co., Ltd...announced that it has received the clinical trial notification from the Center for Drug Evaluation ( CDE ) of the National Medical Products Administration ( NMPA ) approving the new drug clinical trial application ( IND ) for SKB571, a new drug developed by the company...SKB571 is a new type of bispecific ADC, mainly targeting various solid tumors such as lung cancer and gastrointestinal tumors."

New trial • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor

Kelun Biotech: The first IND application for a bispecific ADC new drug has been accepted [Google translation] (163.com) - "On September 5, Kelun Biotech's IND application for SKB571 for injection was accepted by NMPA....SKB571 is an innovative bispecific antibody ADC that targets a variety of solid tumors, including lung cancer and gastrointestinal tumors."

New trial • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor

Kelun Pharmaceutical’s latest announcement: Merck will return the global rights of the SKB315 project to Kelun Biotech [Google translation] (new.qq.com) - "Kelun Pharmaceutical announced that the cooperation project between its holding subsidiary Kelun Biotech and Merck has made progress....Kelun Biotech recently received a written notice from Merck that Merck will exercise its exclusive option for the SKB571 project and pay Kelun Biotech US$37.5 million, and will pay Kelun Biotech further milestone payments after achieving certain development and sales milestones, and will pay tiered royalties calculated based on net sales after SKB571 is commercialized. Kelun Biotech will retain the right to develop, use, manufacture and commercialize SKB571 in mainland China, Hong Kong and Macau. At the same time, Merck will return the global rights of the SKB315 project to Kelun Biotech."

Licensing / partnership • Oncology • Solid Tumor