DB-1310 / DualityBio - LARVOL DELTA

Efficacy, safety, and biomarker analysis of DB-1310 (HER3-targeted ADC) in pretreated HR+/HER2- breast cancer: Updated global phase 1/2a trial (ESMO 2026) - No abstract available

ADC • Biomarker • Clinical • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ERBB3 • HER-2

DB-1310, a HER3-targeted ADC, in pts with advanced solid tumors: Preliminary results from the phase 1/2a trial. (ASCO 2025) - P1/2 | "DB-1310 showed a manageable safety profile and encouraging antitumor activity in pts with heavily pretreated advanced solid tumors, particularly EGFRm NSCLC. Tumor response by dose (efficacy-evaluable)."

Clinical • Metastases • P1/2 data • Anemia • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • ERBB3

DB-1310-O-1001: A Phase 1/2a Study of DB-1310 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=1000 | Recruiting | Sponsor: DualityBio Inc. | Trial completion date: Aug 2026 ➔ Apr 2028 | Trial primary completion date: Aug 2026 ➔ Dec 2027

First-in-human • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ERBB3 • 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."

ADC • Clinical • First-in-human • 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

First clinical data of DB-1310 (HER3-targeted antibody-drug-conjugate), in patients with pretreated hormone receptor-positive/HER2-negative breast cancer: efficacy and safety data from a phase 1/2a trial (SABCS 2025) - P1/2 | "DB-1310 showed promising anti-tumor activity in heavily pretreated HR+/HER2- BC patients. The manageable safety profile observed in the larger Phase 1 part, involving 207 patients, is consistent with that of the BC subpopulation, supporting its further development."

Clinical data • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • EGFR • HER-2

DualityBio’s DB-1310 Granted U.S. FDA Fast Track Designation for HR+/HER2- Breast Cancer (DualityBio Press Release) - "The designation is for the treatment of adult patients with advanced/unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy, CDK4/6 inhibitor, with or without chemotherapy for unresectable or metastatic disease, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy."

Fast track • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Synnovation…Announces Clinical Collaboration with DualityBio to Evaluate the Combination of SNV1521 with Duality’s HER3 ADC, DB-1310 (Businesswire) - "...'This collaboration provides an exciting opportunity to evaluate the combination of two potentially best-in-class therapies...with the aim of demonstrating synergistic efficacy and improving patient outcomes'."

Licensing / partnership • Solid Tumor

DualityBio’s Next-Generation HER3 ADC DB-1310 Granted FDA Fast Track Designation (PRNewswire) - "DualityBio...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310. This designation is for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy."

Fast track • Lung Non-Squamous Non-Small Cell Cancer

ASCO: HER3-Targeted Antibody-Drug Conjugate (ADC) Shows Promise for Treatment-Resistant Solid Tumors (Newswise) - P1/2a | N=1,000 | NCT05785741 | Sponsor: DualityBio Inc. | "A new targeted cancer drug, DB-1310, is showing early signs of effectiveness in patients with advanced solid tumors that have not responded to standard treatments, particularly those with EGFR-mutant non-small cell lung cancer (NSCLC), according to results from an international clinical trial...Among the patients in the trial with EGFR-mutated NSCLC, 44% saw significant shrinkage in their tumors and the drug delayed cancer growth for a median of seven months leading to a very encouraging median overall survival of 18.9 months. Across all cancer types in the trial, 31% of patients responded to the treatment, with an average of 5.5 months before the cancer progressed and a median overall survival of 14.4 months. The side effects of DB-1310 were generally manageable with the most common side effects being low blood counts and nausea."

P1/2 data • Non Small Cell Lung Cancer

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 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