RecruitingPhase 1NCT05768932

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

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

Sponsor

SillaJen, Inc.

Enrollment

260 participants

Start Date

Dec 14, 2022

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing BAL0891, a new investigational drug, in patients with advanced solid tumors or relapsed/refractory acute myeloid leukemia (AML) — a blood cancer. The goal is to determine safe doses and early signs of effectiveness. **You may be eligible if...** - You are 18 or older (or 19 in some locations) - You have an advanced, metastatic, or locally advanced solid tumor that is no longer responding to available treatments — OR — you have AML that has come back or stopped responding to therapy - You have adequate organ function **You may NOT be eligible if...** - You have a cancer type not covered by the study - You are in poor health or have conditions that would prevent you from tolerating the study drug - You have had certain recent treatments that would interfere with this trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBAL0891

BAL0891 is a dual inhibitor of threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK1)

COMBINATION_PRODUCTTislelizumab

Tislelizumab a humanized IgG4 anti-PD-1 monoclonal antibody

COMBINATION_PRODUCTPaclitaxel

Paclitaxel is a natural product with antitumor activity

Locations(15)

Yale New Haven Hospital

New Haven, Connecticut, United States

University of Miami Health System

Coral Gables, Florida, United States

Winship Cancer Institute / Emory University

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

Weill Cornell Medicine- NewYork-Presbyterian Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Korean University Anam Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT05768932

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