BL0175 / Shanghai Best-Link Biosci - LARVOL DELTA

BL0175 Injection for Locally Advanced/Metastatic HR+/HER2− Breast Cancer (HR+, HER2- LA/mBC): Preliminary Results from Dose Escalation Stage of a Phase 1 Study (ESMO 2026) - No abstract available

Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Clinical Trial Comparing the Efficacy and Safety of Different Doses of BL0175 Injection in Treating Postmenopausal Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Shanghai Best-Link Bioscience, LLC

New P2 trial • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

BL0175, a novel nano-mediated polypeptide conjugate of protein degrader, in patients (pts) with locally advanced/metastatic HR+/HER2− breast cancer (HR+, HER2- LA/mBC): Initial results from a phase 1 study. (ASCO 2026) - P1 | "BL0175 demonstrated promising efficacy in pts with HR+, HER2- LA/mBC, including those with prior progression on fulvestrant injection and CDK4/6i-based therapy and in brain metastases. The preliminary results validate BL0175's design rationale, supporting its tumor-targeted delivery and potential for enhanced efficacy at lower doses. These findings warrant further investigation of BL0175 in this patient population."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

BL0175: An intramuscular nano-conjugate of fulvestrant, exhibits superior tumor distribution and antitumor efficacy compared to fulvestrant injection in MCF-7 xenograft mouse model (AACR 2025) - "BL0175 is a unique preclinical nano-drug candidate that exhibited remarkedly enhanced tumor retention and excellent pharmacokinetic properties compared to fulvestrant injection. Furthermore, BL0175 demonstrated superior anti-tumor efficacy against fulvestrant injection in breast cancer. The pre-clinical efficacy and safety studies supported its further development in the clinical stage for HR+ breast cancer therapy."

Preclinical • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER

A Study of Single Dose of BL0175 in Postmenopausal Women (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Shanghai Best-Link Bioscience, LLC

New P1 trial

Micellar Co-Delivery of Fulvestrant and Quercetin to enhance oral Bioavailability: A potential Bioenhancement strategy. (PubMed, Int J Pharm) - "Oral pharmacokinetic studies in rats demonstrated significantly increased relative FVT bioavailability for FVT-MM (2.85- fold) and FVT-QUE-MM (3.71-fold) compared to FVT suspension. These findings suggest that Soluplus®/Pluronic® F127 micelles, particularly those co-loaded with QUE, represent a promising strategy to improve the oral delivery and therapeutic efficacy of FVT."

Journal • Breast Cancer • Oncology • Solid Tumor

A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Shanghai Best-Link Bioscience, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Endometrial Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor