DB-1310 / DualityBio - LARVOL DELTA

DB-1310, a HER3-targeted ADC, in pts with advanced solid tumors: Preliminary results from the phase 1/2a trial. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT05785741 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor • ERBB3

DB-1310, a HER3-targeting antibody-drug conjugate, has synergistic anti-tumor activity with trastuzumab in HER2- and HER3-expressing breast cancer. (PubMed, Cancer Biol Med) - No abstract available

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

DB-1310-O-1001: A Study of DB-1310 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=1000 | Recruiting | Sponsor: DualityBio Inc. | N=287 ➔ 1000

Enrollment change • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ERBB3

DB-1310, an ADC comprised of a novel anti-HER3 antibody conjugated to a DNA topoisomerase I inhibitor, is highly effective for the treatment of HER3-positive solid tumors. (PubMed, J Transl Med) - "These finding demonstrated that DB-1310 exerted potent antitumor activities against HER3 + tumors in in vitro and in vivo models, and showed acceptable safety profiles in nonclinical species. Therefore, DB-1310 may be effective for the clinical treatment of HER3 + solid tumors."

Journal • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • HER-2

A phase 1/2a, multicenter, open-label, non-randomized first-in-human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1310 (a HER3-targeting ADC) in patients with advanced/metastatic solid tumors (AACR 2024) - P1/2 | "DB-1310 is administrated intravenously every 3 weeks as monotherapy, or plus trastuzumab in pts with HER2-positive BC only, until discontinuation criteria are met. The study plans to enroll approximately 95 pts in Phase 1 and 192 in Phase 2a from the United States and China."

Clinical • Metastases • P1/2 data • PK/PD data • Breast Cancer • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • ERBB3 • HER-2

A Study of DB-1310 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=287 | Recruiting | Sponsor: DualityBio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ERBB3

DB-1310, a novel Her3 targeting antibody-drug conjugate, exhibits therapeutic efficacy for solid tumors (AACR 2023) - "To date, only patritumab deruxtecan (U3-1402) showed clinical efficacy in both NSCLC and breast cancer among all Her3-targeting therapies. DB-1310 exhibited its efficacy in tumor models both in vitro and in vivo. These studies suggest that DB-1310 as a novel HER3-targeting ADC showed antitumor efficacy for HER3 positive tumors with good safety profile."

Clinical • Breast Cancer • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ERBB4 • HER-2

A Study of DB-1310 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=287 | Not yet recruiting | Sponsor: DualityBio Inc.

Metastases • New P1/2 trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ERBB3