BR111 / Zhejiang Hisun Pharmaceutical - LARVOL DELTA

HER2 ADC resistance driven by IL-17 signaling and ROR1 upregulation: Overcoming DS-8201 resistance with BRY812 and BR111 (AACR 2026) - "Literature research revealed possible mechanism includes tumor microenvironment remodeling, enhanced cell survival, and immune evasion.BRY812 (an anti-LIV1 ADC conjugated to MMAE) and BR111 (an anti-ROR1 ADC conjugated to eribulin) are novel ADCs that have shown potent antitumor activity in various solid tumors. Further investigation revealed that treatment with HER2-targeting ADCs (DS-8201 and T-DM1) dose-dependently upregulated ROR1 expression, providing a potential mechanism for BR111's efficacy in this resistant setting. In conclusion, our research findings collectively revealed DS-8201 resistance mechanism and provided evidence that BRY812 and BR111 can overcome DS-8201 resistance."

ADC • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Solid Tumor • CXCL1 • HER-2 • IL17A • ROR1

A Study of BR111 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=166 | Recruiting | Sponsor: BioRay Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2028 ➔ Dec 2027 | Trial primary completion date: Aug 2028 ➔ Oct 2027

Enrollment open • Trial completion date • Trial primary completion date • Oncology

Translational medicine studies of BR111, a biparatopic anti-ROR1 antibody drug conjugate for hematological and solid tumor treatment (AACR 2025) - "Studies have also shown that ROR1 levels increase while HER2 levels decrease in cell lines treated with DS-8201, and BR111 showed improved efficacy in DS-8201 resistant cell line as well as in combination with DS-8201. The promising outcome holds great potential as a therapeutic treatment for hematological and solid cancers, offering a better safety profile. BR111 has great potential in further clinical evaluations."

IO biomarker • Endometrial Cancer • Gastric Cancer • Hematological Malignancies • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • HER-2 • SIRPA

A Study of BR111 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=166 | Not yet recruiting | Sponsor: BioRay Pharmaceutical Co., Ltd.

New P1 trial • Oncology

BioRay's ROR1-Targeting Dual-Epitope ADC Drug BR111 Receives Formal Clinical Trial Approval from NMPA (PRNewswire) - "On December 19, 2024, BioRay Pharmaceutical...announced that the National Medical Products Administration (NMPA) has accepted the clinical trial application for its self-developed Class 1 innovative therapeutic biological product, BR111 for injection. BR111 is an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, intended for the treatment of ROR1-positive hematological malignancies and solid tumors."

New trial • Hematological Malignancies • Solid Tumor

Developing a biparatopic anti-ROR1 antibody drug conjugate BR111 for hematological and solid tumor treatment (AACR 2024) - "The promising outcome holds great potential as a therapeutic treatment for hematological and solid cancers, offering a better safety profile. BR111 has great potential in further clinical evaluations."

Hematological Malignancies • Oncology • Solid Tumor