Phase 1 Study of BAL0891 Alone and Combined With Chemotherapy or Tislelizumab in Adults With Advanced Solid Tumors or RelapsedRefractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating BAL0891, a drug that blocks specific proteins involved in cancer cell growth, alone and combined with other therapies in patients with advanced solid tumors or relapsed or refractory acute myeloid leukemia. This Phase 1 study uses a model-based dose escalation design across multiple substudies to find the best dose that is safe and tolerable. The study also aims to further assess the drugs preliminary anti-tumor activity in metastatic triple-negative breast cancer and gastric cancer during a dose-expansion phase. Participants receive BAL0891 intravenously on Day 1 and Day 8 every three weeks in the initial dose-escalation substudy, with doses ranging from 5 mg up to 480 mg. Other dosing schedules may be explored, and BAL0891 will also be tested in combination with tislelizumab or paclitaxel in separate substudies with adjusted doses. Following dose escalation and determination of the recommended Phase 2 dose, the dose expansion stage involves four cohorts of patients with metastatic triple-negative breast cancer or gastric cancer treated with BAL0891 alone or with paclitaxel. During the study, participants will undergo safety and tolerability assessments, laboratory tests, and tumor evaluations at regular intervals. Researchers will monitor adverse events, dose-limiting toxicities, and overall response rates over up to two years. Pharmacokinetics, organ function, and other efficacy measures will also be evaluated. The study includes follow-up visits to track outcomes, with the total participation time depending on treatment response and study timelines.

BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia