Study #2025-0510
A phase 1 study of BAL0891 as monotherapy and in combination with chemotherapy in patients with advanced solid tumors or relapsed or refractory acute myeloid leukemia
MD Anderson Study Status
Enrolling
Treatment Agent
BAL0891, Combination Product: Tislelizumab, Combination Product: Paclitaxel
Description
This study is a multiple cohort, multicenter, open-label Phase 1 study with dose-escalation substudies investigating intravenous (IV) BAL0891 as monotherapy, and in combination with tislelizumab or paclitaxel, to determine the safety and tolerability of increasing doses of BAL0891 in patients with advanced solid tumors or relapsed or refractory acute myeloid leukemia. An adaptive model-based design will be used to guide the dose escalation. Subject assignment to Substudy 1, 2, 3 and 4 will be finalized following approval from the investigator and sponsor. The dose-expansion stage will be conducted with the RP2D to further evaluate the preliminary anti-tumor activity, safety, and tolerability in metastatic TNBC and GC.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Advanced Solid Tumor, TNBC - Triple-Negative Breast Cancer, Gastric Cancer, Leukemia Acute Myeloid Leukemia (AML)
Study phase:
Phase I
Physician name:
Courtney DiNardo
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
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