Phase 12a Study to Evaluate Safety, Tolerability, and Early Effectiveness of DB-1311BNT324 for Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are studying DB-1311BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 12a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavirritonavir and itraconazole. Participants receive intravenous doses of DB-1311BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drugs safety and preliminary antitumor activity. Participants health and cancer are closely followed throughout and after treatment.

A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors