Nanjing Leads Biolabs Launches Phase Ib/II Trial for Opamtistomig in Metastatic Colorectal Cancer

NANJING, China, Oct. 16, 2026 /CourierPR/ -- Nanjing Leads Biolabs Co., Ltd., stock code 9887.HK, announced today that the first patient has been dosed in a Phase Ib/II clinical trial evaluating opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, in combination therapy for metastatic colorectal cancer (mCRC). This milestone marks an important step in the company’s strategy to address immunologically cold tumors, building on the clinical development of opamtistomig in various indications such as extrapulmonary neuroendocrine carcinoma (EP-NEC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), and platinum-resistant ovarian cancer (PROC).

In mCRC, patients with microsatellite stable (MSS) and proficient mismatch repair (pMMR) status account for approximately 95% of cases. Due to insufficient T-cell infiltration in the tumor microenvironment, this patient population responds poorly to conventional immune checkpoint inhibitors. Standard treatment remains centered on chemotherapy combined with targeted therapy, leaving a significant need for new treatment strategies. Opamtistomig conditionally activates 4-1BB, reactivating and substantially expanding T cells while relieving PD-1/PD-L1 immunosuppression. This dual mechanism is expected to help address the immunotherapy gap for this patient population and has the potential to deliver durable, long-tail survival benefits.

The Phase Ib/II clinical trial is led by Academician Xu Ruihua of Sun Yat-sen University Cancer Center and will be conducted concurrently across multiple hospitals nationwide. The aim is to evaluate the efficacy and safety of opamtistomig in combination therapy in patients with mCRC. A translational medicine study of opamtistomig in MSS colorectal cancer has been selected for poster presentation at the 2026 European Society for Medical Oncology (ESMO) Congress. Opamtistomig has also shown a trend of markedly prolonged survival benefits compared with historical data across several representative immunologically cold tumor types, including EP-NEC, BTC, HCC, and PROC, supporting further development of opamtistomig in mCRC.

According to the International Agency for Research on Cancer (IARC), there were approximately 1.93 million new cases and 904,000 deaths globally in 2022, making colorectal cancer (CRC) the third most commonly diagnosed cancer and the second leading cause of cancer-related death worldwide. Data from the National Cancer Center of China show approximately 517,000 new cases and 240,000 deaths in China in 2022, ranking CRC second for incidence and fourth for mortality among all malignancies. Approximately 15% to 30% of patients with CRC have metastatic disease at initial diagnosis, and 20% to 50% of patients initially diagnosed with localized disease eventually develop mCRC. Despite advances in treatment, mCRC remains associated with poor prognosis, with a five-year survival rate of only approximately 15%. Currently, immunotherapies are primarily approved for patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) CRC. However, these patients account for only approximately 5% of mCRC cases, whereas approximately 95% of patients have microsatellite-stable (MSS) or mismatch repair-proficient (pMMR) disease, which generally exhibits limited responsiveness to conventional immunotherapy, highlighting a significant unmet medical need.

Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Currently, opamtistomig is being evaluated in 14 indications, including one pivotal single-arm registrational study, one confirmatory Phase III study, and nine proof-of-concept studies, covering major indications such as non-small cell lung cancer (NSCLC) and multiple cold tumors. To date, opamtistomig has demonstrated robust antitumor activity across seven tumor types, extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC), highlighting its clinical value and broad therapeutic promise.

Developed using Leads Biolabs’ proprietary X-body bispecific platform, opamtistomig is designed to simultaneously block PD-1/PD-L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential.