SKB315 / Sichuan Kelun Pharma - LARVOL DELTA

SKB315-I-01: A Study of SKB315 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=246 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: Feb 2026 ➔ Jun 2028 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Solid Tumor • CLDN18

SKB315, a novel claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors including gastric/ gastroesophageal junction cancer (GC/GEJC): A phase I study (ESMO 2025) - P1 | "SKB315 is a novel ADC designed to target CLDN18.2, developed with a proprietary Kthiol (pyrimidine-thiol) linker to conjugate a belotecan-derivative topoisomerase I inhibitor as the payload. Conclusions SKB315 demonstrated a manageable safety profile in pts with advanced solid tumor and showed a promising antitumor activity in pts with CLDN18.2-expressing advanced GC/GEJC. These findings warrant further evaluation of SKB315 in CLDN18.2-expressing solid tumors."

Clinical • Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

The 2025 European Society for Medical Oncology (ESMO) Congress…will present results from multiple clinical studies at the congress, including data from its TROP2 ADC sacituzumab tirumotecan (sac-TMT), HER2 ADC A166 (trastuzumab botidotin), and CLDN18.2 ADC SKB315. (PRNewswire) - "Among these, two Phase III clinical studies of sac-TMT were selected for the Latest Breakthrough Abstracts (LBA) and presented as oral reports, including one featured in the Presidential Symposium; one Phase III clinical study of A166 was selected for LBA and presented as oral report."

Clinical data • Late-breaking abstract • Castration-Resistant Prostate Cancer • Cervical Cancer • Endometrial Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer

SKB315 (CLDN18.2 ADC): (PRNewswire) - "The company is conducting a Phase 1b clinical trial of SKB315 and have initiated the exploration in combination with immunotherapy for the treatment of GC/GEJC. Results of a Phase 1 study of SKB315 will be presented at 2025 ESMO Congress in October 2025."

P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002) (clinicaltrials.gov) - P1/2 | N=304 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Solid Tumor

Kelun-Biotech's Novel CLDN18.2 ADC SKB315 IND in Combination with Tagolizumab Receives NMPA Approval for the First-Line Treatment of Gastric/Gastro-oesophageal Junction Cancer (PRNewswire) - "Sichuan Kelun-Biotech Biopharmaceutical...announced that the Company has received a clinical trial notice approving the investigational new drug application for the its CLDN18.2-directed antibody-drug conjugate (ADC) SKB315 in combination of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody (mAb) tagitanlimab for the first-line treatment of gastric cancer / gastro-oesophageal junction cancer (GC/GEJC) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)."

New trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A Study of SKB315 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=206 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: May 2024 ➔ Feb 2026 | Trial primary completion date: May 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Solid Tumor • CLDN18

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002) (clinicaltrials.gov) - P1/2 | N=304 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jan 2026 ➔ Jun 2025 | Trial primary completion date: Jan 2026 ➔ Jun 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

MK-1200-002: Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=304 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • 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

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=304 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Phase classification: P2 ➔ P1/2 | Trial completion date: Mar 2027 ➔ Jan 2026 | Trial primary completion date: Jan 2027 ➔ Jan 2026

Metastases • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Comments on Kelunbotai's 2023 annual report: SKB264's overseas and domestic clinical advancement exceeds expectations, and the nuclear drug track has promising prospects [Soochow Pharmaceutical Zhu Guoguang Team] [Google translation] (Sohu.com) - "Kelonbotai has deeply laid out the popular ADC track, and a number of hot products are ready for launch: A166 (HER2 ADC), the first indication for HER2+ breast cancer, has completed the NDA submission and is expected to become the first domestic ADC in the country to treat HER2-positive BC. Clinical studies on HER2+ GC (2L) and HER2+ CRC (3L) are in progress. SKB315 (CLDN 18.2 ADC) is the second ADC with the same target in the world to start patient enrollment."

Non-US regulatory • Trial status • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=304 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=304 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

Metastases • New P2 trial • Oncology • Solid Tumor

Merck terminates some of the exclusive licenses granted to it by Colombote. The latter's stock price fell more than 7% today. [Google translation] (Daily Economic News - NBD) - "Early...Kelun Pharmaceutical announced that Kelonbotai received notice from Merck that the latter would terminate the development, manufacturing and commercialization of a preclinical ADC ( Antibody drug conjugate) assets; not exercise the exclusive option granted to it by Colombote to obtain an exclusive license for another preclinical ADC asset....Kelen Pharmaceutical also said that Merck said it would continue to advance SKB264/MK-2870, SKB315/MK-1200, an undisclosed phase I project and other preclinical ADC projects. It also plans to accelerate the clinical development project of SKB264/MK-2870, and recently announced the initiation of phase III clinical trials for specific non-small cell lung cancer patients."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

"SKB315: developed by Kelun, licensed to Merck" (@Pharmews)

"SKB315https://www.adcreview.com/drugmap/skb315/" (@OncoZine)

Review

"$MRK 2nd licensed ADC from Kelun likely Claudin18.2 (SKB315) as well, utilizing same belotecan-derived payload as $MRK previously licensed only now disclosed TROP2 ADC SKB264." (@jq1234t)

CLDN18 • CLDN8 • TROP2

A Phase 1 Clinical Study of SKB315 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=206 | Recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

New P1 trial • Oncology • Solid Tumor • CLDN18