BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia (NCT05768932)
A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy or Tislelizumab in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Yale New Haven Hospital — New Haven, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- Yale New Haven Hospital — New Haven, Connecticut
- University of Miami Health System — Coral Gables, Florida
- Winship Cancer Institute / Emory University — Atlanta, Georgia
- University of Michigan — Ann Arbor, Michigan
- New York Medicine-New York-Presbyterian Hospital — New York, New York
- Montefiore Medical Center - Montefiore Hospital — New York, New York
- Montefiore Medical Center — The Bronx, New York
- OHSU Knight Cancer Institute — Portland, Oregon
- Mary Crowley Cancer Research — Dallas, Texas
- Baylor University Medical Center — Dallas, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul,
- Asan Medical Center — Seoul,
- Korean University Anam Hospital — Seoul,
- Samsung Medical Center — Seoul,
- Seoul National University Hospital — Seoul,
- Severance Hospital, Yonsei University Health System — Seoul,
📞 Contact the Study Coordinator
Phone: 02-368-2600
Email: patient_inquiry@sillajen.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.