D3L-001 / D3 Bio - LARVOL DELTA

A phase 1, dose escalation and expansion study evaluating the safety, tolerability, PK, PD, and preliminary efficacy of D3L-001 monotherapy in subjects with HER2+ advanced solid tumors (SITC 2024) - P1 | "D3L-001 has shown potent anti-tumor efficacy in both trastuzumab/T-DM1 sensitive and resistant xenograft models of various histologies.3 D3L-001 has been approved by the US FDA, AUS TGA and China CDE to enter a first-in-human (FIH) phase 1 (Ph1) dose escalation and expansion trial. Ethics Approval The protocol and all amendments were approved by the appropriate institional review board or independent ethics committee at each participating study site. The study was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines."

Clinical • Metastases • Monotherapy • P1 data • Oncology • Solid Tumor • CD47 • HER-2 • SIRPA

A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: D3 Bio (Wuxi) Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Monotherapy • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD47 • HER-2

Deshengji Pharmaceutical’s HER2/CD47 dual antibody has been clinically approved in China [Google translation] (163.com) - "On September 4, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that D3L-001, a Class 1 new drug applied by Deshengji Pharmaceuticals, has received implicit approval for clinical trials and is planned to be developed for HER2-positive advanced solid tumors."

New trial • Oncology • Solid Tumor • HER-2

A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: D3 Bio (Wuxi) Co., Ltd

Metastases • Monotherapy • New P1 trial • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD47 • HER-2

D3L-001, a novel bispecific antibody targeting HER2 and CD47, demonstrates potent preclinical efficacy in solid tumors. (AACR 2023) - "Many HER2-targeted drugs, including trastuzumab, pertuzumab, lapatinib, trastuzumab emtansine (T-DM1), and trastuzumab deruxtecan (T-DXd), have been approved for treatment of HER2-positive early and metastatic breast cancer (BC)...In both in vitro and in vivo studies using breast cancer HCC1954, JIMT-1 and gastric cancer N87 models, we observed a synergistic effect in the combination of Trastuzumab with Magrolimab...D3L-001 also displayed potent and comparable in vivo efficacy as Enhertu in gastric N87 model, and it showed synergistic in vivo efficacy, when combining with Pertuzumab or Paclitaxel, in breast HCC1954, JIMT-1 and gastric cancer N87 models. D3L-001, a novel HER2×CD47 bsAb, demonstrated potent anti-tumor effect in a variety of solid tumor models via HER2 guided CD47 co-blocking. D3L-001, a novel HER2×CD47 bsAb, demonstrated potent anti-tumor effect in a variety of solid tumor models via HER2 guided CD47 co-blocking. It also showed synergistic..."

Preclinical • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD47 • HER-2 • SIRPA