A Phase I Study of BB-1705 Given by Intravenous Infusion for Locally Advanced or Metastatic Solid Tumors Assessing Safety, Tolerability, Pharmacokinetics, and Early Anti-Tumor Effects

What this Trial Is About

Researchers are evaluating BB-1705, an antibody-drug conjugate, in patients with locally advanced or metastatic solid tumors that have progressed after standard treatments. This Phase I study has two parts a dose-escalation phase to find the safest and most effective dose, and a cohort expansion phase to further assess safety, how the drug moves through the body, and its early anti-tumor effects. BB-1705 is given as an intravenous infusion every three weeks for up to eight cycles. During the dose-escalation phase, different doses are tested to find the maximum tolerated dose, followed by a cohort expansion phase where selected doses are given to more patients to monitor safety and preliminary effectiveness. The study is open label and non-randomized. Participants will have regular visits for safety checks, blood tests, and tumor assessments using imaging every 6 to 9 weeks for up to two years. Researchers will closely track side effects, drug levels, immune responses, tumor response, and progression-free survival. The total study duration includes treatment cycles and follow-up for adverse events and clinical outcomes.

A First-in-human of Multiplle Doses of BB-1705 in Subjects With Locally Advanced/Metastatic Solid Tumors