BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumor, TNBC - Triple-Negative Breast Cancer, Gastric Cancer, Leukemia Acute Myeloid Leukemia (AML)
In brief
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.
Key facts
- Study ID
- NCT05768932
- Run by
- SillaJen, Inc.
- People needed
- 260
- Starts
- 2022-12-14
- Expected to finish
- 2026-12-24
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
- University of Miami Health System — Coral Gables, Florida, United States (enrolling)
- Winship Cancer Institute / Emory University — Atlanta, Georgia, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- New York Medicine-New York-Presbyterian Hospital — New York, New York, United States (enrolling)
- Montefiore Medical Center - Montefiore Hospital — New York, New York, United States (enrolling)
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- Seoul National University Hospital — Seoul, South Korea (enrolling)
- Severance Hospital, Yonsei University Health System — Seoul, South Korea (enrolling)
- Baylor University Medical Center — Dallas, Texas, United States (enrolling)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, South Korea (enrolling)
- Asan Medical Center — Seoul, South Korea (enrolling)
- Korean University Anam Hospital — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- OHSU Knight Cancer Institute — Portland, Oregon, United States
- Mary Crowley Cancer Research — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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