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

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 cond

Trial Details

NCT ID
NCT05768932
Phase
PHASE1
Sponsor
SillaJen, Inc.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • BAL0891
  • Tislelizumab
  • Paclitaxel
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Coral Gables, Florida, United States|25.72149,-80.26838
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Ann Arbor, Michigan, United States|42.27756,-83.74088
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Informed consent signed by the patient prior to any study-related procedure indicating that they understand the purpose of, and procedures required…
  • Male or female aged ≥18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
  • Patients with incurable advanced/metastatic solid tumor disease refractory to or intolerant of existing therapy known to provide clinical benefit f…
  • Note: Patients with non-CNS tumors participating during dose escalation may have inactive CNS metastasis, defined as 4 weeks after either brain met…

For full eligibility, visit ClinicalTrials.gov.

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