A Phase 1 Study to Evaluate Safety and Early Effects of OT-A201 Alone or With Other Treatments in Adults With Certain Blood Cancers or Solid Tumors

What this Trial Is About

Researchers are evaluating OT-A201, a bispecific antibody, for its safety and preliminary effectiveness in treating patients with certain blood cancers and solid tumors. This phase 1 study aims to establish safe dosage levels and understand how well patients tolerate the treatment alone and when combined with other approved cancer drugs. The study is sponsored by Onward Therapeutics and focuses on patients with advanced or relapsed cancers who have exhausted standard therapies. Participants may receive OT-A201 through intravenous infusion once a week or every two weeks depending on safety data. The study includes several groups OT-A201 alone, OT-A201 with immunomodulatory drugs like lenalidomide or pomalidomide, and OT-A201 combined with other treatments such as bevacizumab or paclitaxel. The dose-escalation phase determines the recommended doses, followed by an expansion phase to further explore anti-cancer activity. During the study, participants will undergo various assessments including biopsies or bone marrow aspirations if recent samples are unavailable, regular clinical laboratory tests, and monitoring of side effects. Researchers will evaluate maximum tolerated dose and safety profile over 28 days and up to 6 months. The study involves careful observation to track responses and adverse events, lasting until July 2027.

First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors