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BAL0891 for Advanced Solid Tumors or Relapsed/Refractory AML

This study is testing a new drug called BAL0891, alone or with other treatments like tislelizumab or paclitaxel, for people with advanced solid tumors (including triple-negative breast cancer and gastric cancer) or acute myeloid leukemia (AML) that has come back or not responded to previous treatments. BAL0891 works by targeting two specific proteins (TTK and PLK1) in cancer cells. The main goals are to find a safe dose of BAL0891 and see how well it works against the cancer. We are looking for about 260 participants aged 18 and older. The study is currently open, but its exact status is unclear.

Study design
This is an open-label Phase 1 study, meaning both you and the study team will know which treatment you are receiving. It involves increasing doses of BAL0891 to find the safest and most effective amount.
What's involved
You would receive BAL0891 intravenously (IV) on Day 1 and Day 8 every 3 weeks. Safety and tolerability will be measured after your first dose, for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
Your overall response to treatment will be measured every 3 months (±14 days) after your first dose, for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05768932

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
SillaJen, Inc.
~260 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:BAL0891TislelizumabPaclitaxel

At a glance

Recruiting sites
15 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured over After first dose, up to 2 years
+2 more outcomes measured

Conditions

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

Explore related trials

Acute Myeloid LeukemiaGastric CarcinomaSolid NeoplasmTriple-Negative Breast Carcinoma

Where it's being run

17 sites across 8 states
South Korea6
New York3
Texas3
Connecticut1
Florida1
Georgia1
Michigan1
Oregon1

Study leadership

  • SillaJen Inc. · STUDY_DIRECTOR · SillaJen, Inc.

Who to contact

SillaJen Inc.
[email protected]
02-368-2600
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

IHC 0 or 1 fluorescence in situ hybridization (FISH) negative (or equivalent negative test)
Patients with IHC 2 must have a negative by FISH (or equivalent negative test) iii. Patients with a history of different breast cancer phenotypes (i.e., ER/PgR/HER2 Positive) must obtain pathological confirmation of triple-negative disease in at least one of the current sites of metastasis.

What this trial measures

  • Part 1: Number of Participants With Adverse Events as a Measure of Safety and TolerabilityAfter first dose, up to 2 years

    Safety is collected through summaries of AE(Adverse Event)s, safety laboratory evaluations, PK evaluations, physical examinations, vital signs, and ECGs using CTCAE v5.0.

  • Part 1: Number of Participants With the DLT (Dose-limiting toxicity)s as a Measure of maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)After first dose and within 7 days of End of Treatment, up to 2 years

    DLTs are collected through BLRM-EWOC.

  • Part 2: Overall response rate (ORR) for all subjectsEvery 3 months (±14 days) after first dose, up to 2 years

    The proportion of patients with confirmed complete response (CR) or partial response (PR) by RECIST 1.1/iRECIST (substudy 2 only) during the dose expansion phase.