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

SillaJen, Inc.

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.

Description

Substudy 1 (monotherapy dose-escalation cohorts) This study will be initiated with enrollment into Substudy 1 and will estimate the safety, tolerability, PK, and PD of increasing doses of BAL0891 in patients with advanced solid tumors. The starting dose will be 5 mg based on the GLP (Good Laboratory Practice) toxicology studies. Dose escalation will comprise a dose range from a dose of 5 mg up to a maximum absolute dose of 480 mg, with eight nominal dose levels (DLs) of 5 / 10 / 20 / 40 / 80 / 160 / 320 / 480 mg. Intra-patient dose escalations are only allowed for patients enrolled in single-p…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

1.1. Inclusion criteria: Substudy 1, 2, 3 and Dose expansion Each patient must meet all the following inclusion criteria. 1. Informed consent signed by the patient prior to any study-related procedure indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. 2. Male or female aged ≥18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening. 3. Patients with incurable advanced/metastatic solid tumor disease refractory to or intolerant of existing therapy known to provide clinical benefit…

Interventions

Drug
BAL0891
BAL0891 is a dual inhibitor of threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK1)
Combination Product
Tislelizumab
Tislelizumab a humanized IgG4 anti-PD-1 monoclonal antibody
Combination Product
Paclitaxel
Paclitaxel is a natural product with antitumor activity

Locations (15)

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
Weill Cornell Medicine- NewYork-Presbyterian Hospital
New York, New York
Montefiore Medical Center
The Bronx, New York