Phase I Study of CBA-1535 Alone and With Pembrolizumab for Advanced Solid Tumors Evaluating Safety, Tolerability, and Biomarker Profiles

What this Trial Is About

Researchers are evaluating CBA-1535, a T cell engager, in patients with advanced solid tumors who have no standard treatment options or who cannot tolerate or do not respond to standard therapies. This is a first-in-human, multicenter, open-label Phase I study that aims to assess the safety, tolerability, pharmacokinetics, biomarker profiles, and preliminary efficacy of CBA-1535 alone and in combination with pembrolizumab. The study has two parts. In Part 1, patients receive escalating doses of CBA-1535 alone as a weekly intravenous infusion on Days 1, 8, and 15 of each 21-day cycle. Part 2 involves dose escalation of CBA-1535 combined with fixed-dose pembrolizumab given intravenously every three weeks on Day 1 of each cycle. Dose escalation continues until dose-limiting toxicity or disease progression occurs. The study also determines recommended doses for further research. Participants will be monitored for dose-limiting toxicities during the first 21 days of treatment and adverse events for up to about 24 months. Blood samples will be collected to measure drug levels and biomarker changes. Researchers will evaluate the safety, tolerability, and preliminary anti-tumor activity. Total participation may last up to two years with regular clinical assessments and laboratory tests throughout the study.

A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.