BioRay Pharmaceutical Advances Novel Dual-Payload TROP2 ADC, BR113, into First-in-Human Clinical Trials

August 17, 2026

AllSci China

Overview

China’s BioRay Pharmaceutical has initiated a first-in-human Phase I trial for BR113, an innovative dual-payload TROP2 antibody-drug conjugate (ADC) targeting patients with advanced solid tumors. BR113 distinguishes itself from conventional single-payload ADCs by integrating both a cytotoxic topoisomerase I inhibitor and an immunostimulant onto a single antibody backbone. This trial, set to begin patient enrollment in August 2026, aims to evaluate key metrics like objective response rate (ORR) and progression-free survival (PFS), potentially ushering in a new era for TROP2-positive solid cancer therapy.

In Depth

Introduction

China’s BioRay Pharmaceutical has initiated a First-in-Human (FIH) Phase I clinical trial for BR113, an innovative dual-payload TROP2 antibody-drug conjugate (ADC) designed for patients with advanced solid tumors. BR113 is garnering significant attention as a next-generation therapeutic with the potential to overcome the limitations of conventional ADCs.

Technological Innovation

The defining characteristic of BR113 is its “dual-payload” design, which combines two distinct types of therapeutic agents—a cytotoxic topoisomerase I inhibitor payload and an immunostimulant—onto a single antibody backbone. This innovative architecture aims to attack cancer through a dual mechanism: direct cytotoxic action against cancer cells and activation of an anti-tumor immune response. While conventional ADCs typically carry a single cytotoxic payload, BR113’s design holds the potential to significantly enhance therapeutic efficacy against TROP2-positive tumors.

Clinical Trial Design

This Phase I trial is specifically designed to evaluate BR113’s safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Key efficacy endpoints include Objective Response Rate (ORR) and Progression-Free Survival (PFS). Patient enrollment for advanced solid tumor patients is scheduled to commence in August 2026.

Industry Context and TROP2 Targeting

TROP2 is a cell surface protein highly overexpressed in numerous epithelial malignancies, including breast, lung, gastric, and ovarian cancers. Its involvement in cancer proliferation, metastasis, and invasion establishes it as a promising therapeutic target. While TROP2-targeting ADCs like Sacituzumab govitecan have already demonstrated clinical success, dual-payload ADCs such as BR113 are exploring avenues to overcome treatment resistance and extend efficacy to a broader patient population. This innovative approach expands the design paradigm for ADCs, potentially fostering a paradigm shift in cancer therapy. The proactive engagement of Chinese biopharmaceutical companies in such cutting-edge technological development underscores their growing presence in the global drug discovery landscape.

Future Outlook

The results of BR113’s Phase I trial will be critically important in evaluating the efficacy and safety of dual-payload ADCs for TROP2-positive solid tumor treatment. Promising outcomes would strongly validate the potential of this next-generation ADC platform and offer new strategies to further enhance the effects of cancer immunotherapy. BioRay Pharmaceutical aims to accelerate BR113’s clinical development through this trial, ultimately striving to deliver a breakthrough therapeutic to patients. Researchers and clinicians worldwide will closely monitor whether this uniquely designed ADC can offer new hope for treating refractory solid tumors.

Source: https://allsci.com/news/first-in-human-trials/trop-2-adc-clinical-trial-bioray-launches/

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