F0024 / Shanghai Fudan-Zhangjiang - LARVOL DELTA

F0024-101: A Study of FDA018-ADC in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=78 | Active, not recruiting | Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

FDA018-ADC Vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - P3 | N=350 | Recruiting | Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Fudan Zhangjiang (688505.SH): The first patient was enrolled in the Phase III clinical trial of FDA018 antibody conjugate for injection for the treatment of triple-negative breast cancer [Google translation] (Sina Corp) - "Fudan Zhangjiang...announced that the first subject has been enrolled in the Phase III clinical study of the company's injectable FDA018 antibody conjugate...for the treatment of triple-negative breast cancer (TNBC)...recently."

Trial status • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - P3 | N=350 | Not yet recruiting | Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Metastases • New P3 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Dose escalation and expansion results from the phase I study of F0024, a trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors. (ASCO 2024) - P1 | "Background: F0024 is an antibody-drug conjugate (ADC) targeting Trop-2, an intracellular calcium signaling transducer overexpressed on many epithelial tumors, for delivery of SN-38, the active metabolite of irinotecan. In this first-in-human study of F0024, treatment was generally well tolerated and MTD was not yet reached up to 12 mg/kg. F0024 demonstrated encouraging preliminary antitumor activity in heavily pretreated TNBC pts, especially in 10 and 12 mg/kg. Clinical trial information: NCT05174637."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Study of FDA018-ADC in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=78; Recruiting; Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Clinical • New P1 trial • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

Fudan-Zhangjiang Bio’s anti-Trop2 ADC under trial review in China (GBI Health) - "China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd’s (01349.HK:688505.SH) clinical trial filing for FDA018, an anti-trophoblast cell-surface antigens2 (TROP2) antibody drug conjugate (ADC), has been accepted for review by the National Medical Products Administration. The drug, filed as a Category 1 therapeutic biologic product, will be assessed as a treatment for solid tumors."

Non-US regulatory • Oncology • Solid Tumor