Phase I/II, Two-Part, Multicenter First-in-Human Study of DS-7300a in Subjects with Advanced SolidMalignant Tumors

This study will test the investigational drug, DS-7300a, for the first time in humans. DS-7300a is an antibody-drug conjugate (ADC) being developed as an anti-cancer agent. ADCs are made up of a monoclonal antibody chemically linked to a drug. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Some antibody-drug conjugates are used to treat cancer. Also called ADC. This study is in one single group of participants with advanced solid tumors who have not been cured by other treatments. The study will be conducted in two parts. The primary purpose of the parts are: Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of DS-7300a. Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of DS-7300a.

Are you Eligible? (Inclusion Criteria)

• Aged 18 or older
• Has diagnosed advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, prostate cancer, breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
• Never had prior treatment with B7-H3 targeted agent.
• Never had prior treatment with certain kinds of topoisomerase I inhibitors (e.g., trastuzumab deruxtecan)