laventatug tivedotin (BRY812) / BioRay Biopharmaceutical - 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

Translational medicine studies of BRY812, an anti-LIV-1 antibody drug conjugate for cancer therapeutics (AACR 2025) - "Finally, BRY812 has shown improved efficacy in DS-8201 resistant cell line compared to the parental cell line. These results showed that BRY812, either as a monotherapy or in combination with other drugs, has a significant potential for application in various solid tumor indications, as well as in patients who are resistant to existing therapies."

ADC • IO biomarker • Breast Cancer • Endometrial Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Melanoma • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR • SLC39A6

BRY812, an anti-LIV-1 antibody drug conjugate with novel conjugation method for cancer therapeutics (AACR 2024) - "With best-in-class anti-tumor efficacy in various models, BRY812 demonstrated a wider therapeutic window for cancer treatment. BRY812 is currently in Phase Ia dose escalation stage clinical trial to explore the maximum tolerate dosage (MTD) from 0.25 to 3.6 mg/kg Q3W in patients with advanced malignancies."

ADC • Breast Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Melanoma • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR • SLC39A6

Phase IIa Study of BRY812 Monotherapy in Advanced Gynecological Malignancies (clinicaltrials.gov) - P2 | N=56 | Not yet recruiting | Sponsor: BioRay Pharmaceutical Co., Ltd.

Monotherapy • New P2 trial • Gynecologic Cancers • Oncology

A Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1 | N=164 | Recruiting | Sponsor: BioRay Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology

Association of LIV-1 expression with clinical efficacy in patients with advanced breast cancers treated with BRY812. (ASCO 2025) - P1 | "We demonstrated that LIV-1 is highly expressed in the tumor cells of breast cancer patients. Expression level of LIV-1 (PS2+) is a statistically indicative biomarker for ORR treating with BRY812. Breast cancer patients with higher LIV-1 expression are expected to have better clinical outcome from BRY812 treatment."

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor

The safety, tolerability, and efficacy of BRY812 in patients with advanced solid tumors: Preliminary results from the phase I clinical study. (ASCO 2025) - P1 | "BRY812 demonstrated favorable safety and tolerability profile, with promising clinical efficacy in patients with advanced solid tumors. Further dose optimization and clinical efficacy will be explored in Phase Ib. Clinical trial information: NCT06038058."

Clinical • Metastases • P1 data • Breast Cancer • Corneal Abrasion • Hematological Malignancies • Neutropenia • Oncology • Pain • Solid Tumor

Investigation of the cytotoxic effects and mechanisms of the SLC39A6-targeting ADC drug BRY812 in CRC. (PubMed, Sci Rep) - "This study has identified SLC39A6 as a potential therapeutic target in CRC. BRY812 is expected to become a highly promising therapeutic drug, bringing new hope to patients with CRC."

Journal • Colorectal Cancer • Oncology • Solid Tumor • SLC39A6

BioRay Announces First-Patient-In for Phase I Clinical Study of BRY812, a Novel LIV-1 Targeting Antibody Drug Conjugate (PRNewswire) - "BioRay Pharmaceutical Co., Ltd...announced that the first patient has been dosed in the Phase I Clinical trial of BRY812, a third-generation antibody-drug conjugate (ADC) targeting LIV-1 for the treatment of advanced malignant tumors. The leading institution of this clinical trial is Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and the principal investigators are academician Song Erwei and Professor Yao Herui."

Trial status • Oncology • Solid Tumor

A Phase I Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1 | N=164 | Not yet recruiting | Sponsor: Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd

Metastases • New P1 trial • Gastrointestinal Cancer • Oncology

BioRay Filed IND Application for BRY812, a Novel Antibody Drug Conjugate Targeting LIV-1 (PRNewswire) - "BioRay Pharmaceutical...announced that the Investigational New Drug (IND) application for the clinical trial of its proprietary BRY812, a novel antibody-drug conjugate (ADC) targeting human LIV-1 for the treatment of advanced malignant tumors, has been accepted by the China National Medical Products Administration (NMPA) (Acceptance No. CXSL2300366)....Globally, no LIV-1 targeting ADC has received marketing approval yet, and BioRay's BRY812 is anticipated to be the second LIV-1 ADC that reaches the clinical stage."

New trial • Oncology • Solid Tumor