SKB500 / Sichuan Kelun Pharma - LARVOL DELTA

SKB500 (a novel B7-H3–targeted antibody-drug conjugate) in patients with extensive-stage small cell lung cancer (ES-SCLC): Results from a phase I study (ESMO 2026) - No abstract available

ADC • Clinical • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

An open-label, first-in-human study of SKB500 in patients with locally advanced or metastatic solid tumors. (ASCO 2026) - P1 | "SKB500 demonstrated a manageable safety profile and promising antitumor activity in patients with treatment-refractory advanced solid tumors, with notable efficacy in SCLC and ESCC cohorts, supporting further clinical development."

Clinical • First-in-human • Metastases • P1 data • Esophageal Squamous Cell Carcinoma • Infectious Disease • Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • CD276

SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026 (PRNewswire) - "As of March 31, 2026, efficacy data showed: Antitumor activities were observed across multiple solid tumor types, including SCLC, ESCC, HNSCC, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and nasopharyngeal carcinoma (NPC). Among 124 patients treated at 12 mg/kg with at least 6 weeks of follow-up, the objective response rate (ORR) was 42.7%, and the disease control rate (DCR) was 83.9%. Among the treated SCLC patients (n=40), the ORR was 65.0% (95% CI: 48.3, 79.4), median progression-free survival (mPFS) was 7.2 months (95% CI: 4.3, NE), DCR was 95.0%, and mDOR was 5.8 months. Among the treated ESCC patients (n=37), the ORR was 54.1%."

First-in-human • P1 data • Esophageal Squamous Cell Carcinoma • Lung Neuroendocrine Carcinoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

Kelun-Biotech Announces Three Clinical Study Results Selected for Oral Presentations at 2026 ASCO Annual Meeting (Businesswire) - "In this meeting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) will present results from three clinical studies, including data from its TROP2 ADC sacituzumab tirumotecan (sac-TMT, next-generation selective RET inhibitor lunbotinib fumarate (A400/EP0031) and novel ADC SKB500."

P1 data • P2 data • P3 data • Non Small Cell Lung Cancer

SKB500-II-02: SKB500 Combinations in Patients With Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • 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

SKB500 Combinations in Patients With Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

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

A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Trial primary completion date: Jul 2025 ➔ Jul 2027

Trial primary completion date • Oncology • Solid Tumor

SKB500 and SKB501: (PRNewswire) - "Novel ADC drugs with verified targets but differentiated payload-linker strategies. The company been received a clinical trial notice approving the IND application of SKB501 and SKB500, respectively, for advanced solid tumors from the NMPA."

New trial • Solid Tumor