drugset
drugset / Trial / NCT05768932

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

NCT05768932 ↗

Phase 1 Recruiting 260 enrolled SillaJen, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2022-12-14
Primary completion
2026-12-24
Completion
2026-12-24

Drugs

EvaluationDrugModalityDoseRoute
Subject BAL0891 Unknown 5 mg Intravenous
Subject BAL0891 Unknown 10 mg Intravenous
Subject BAL0891 Unknown 20 mg Intravenous
Subject BAL0891 Unknown 40 mg Intravenous
Subject BAL0891 Unknown 80 mg Intravenous
Subject BAL0891 Unknown 160 mg Intravenous
Subject BAL0891 Unknown 320 mg Intravenous
Subject BAL0891 Unknown 480 mg Intravenous
Subject Paclitaxel Small molecule 70 mg/m2 —
Subject Paclitaxel Small molecule 80 mg/m2 —
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous

Indications

acute myeloid leukemia gastric cancer triple-negative breast carcinoma