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

NCT05768932 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor
  • TNBC - Triple-Negative Breast Cancer
  • Gastric Cancer
  • Leukemia Acute Myeloid Leukemia (AML)

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

Sponsors & Collaborators

  • SillaJen, Inc.

    lead INDUSTRY

Principal Investigators

  • SillaJen Inc. · SillaJen, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2026-12-24
Completion
2026-12-24
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05768932 on ClinicalTrials.gov