Actively Recruiting
A Phase 1 Study of BAL0891 Alone and With Chemotherapy or Tislelizumab in Patients With Advanced Solid Tumors or Relapsed/Refractory Acute Myeloid Leukemia
Led by SillaJen, Inc. · Updated on 2026-03-27
260
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating intravenous BAL0891, both alone and combined with tislelizumab or paclitaxel, in patients with advanced solid tumors or relapsed/refractory acute myeloid leukemia (AML). This Phase 1, open-label study uses dose-escalation substudies to assess the safety and tolerability of increasing BAL0891 doses. The study also includes a dose-expansion phase to evaluate preliminary anti-tumor activity in metastatic triple-negative breast cancer (TNBC) and gastric cancer (GC). The trial uses an adaptive model-based design to guide dose increases, with subject group assignments finalized by investigators and sponsors. The study consists of four substudies: Substudy 1 tests BAL0891 alone in dose-escalation cohorts, starting at 5 mg and increasing up to 480 mg, given intravenously on Days 1 and 8 every 3 weeks. Substudies 2 and 3 evaluate BAL0891 combined with tislelizumab or paclitaxel, respectively, with dose escalation following safety data from Substudy 1. Substudy 4 examines BAL0891 monotherapy in relapsed/refractory AML patients with a similar dose-escalation approach. The dose-expansion phase follows to further assess recommended doses in cohorts of TNBC and GC patients receiving BAL0891 alone or with paclitaxel. Participants will receive study treatments intravenously on scheduled days every 3 or 4 weeks, depending on the regimen. Researchers will monitor safety, tolerability, pharmacokinetics, pharmacodynamics, and tumor response through clinical assessments, lab tests, and imaging over up to two years. Main outcomes include adverse events, dose-limiting toxicities, overall response rates, and survival measures. Long-term follow-up will evaluate treatment effects and safety in this advanced cancer and leukemia population.
CONDITIONS
Brief Title
BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Male or female aged 18 years or older at screening
- Patients with incurable advanced or metastatic solid tumors refractory or intolerant to existing therapies
- For dose expansion TNBC cohorts: histologically confirmed triple-negative breast cancer with progression after anthracycline and/or taxane therapy
- For dose expansion GC cohort: histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma with progression after platinum/fluoropyrimidine therapy
- Documentation of HER2/neu status and prior treatment with HER2/neu inhibitors if positive (GC cohort)
- No more than 3 prior lines of therapy for advanced disease
- For Substudy 3 or cohorts 3 and 4, progression must be more than 12 months after prior taxane treatment
- Minimum of one prior systemic regimen for advanced or metastatic disease (dose expansion patients)
- Eastern Cooperative Oncology Group performance status 0 or 1 (0 to 2 for Substudy 4)
- Measurable tumor per RECIST 1.1 criteria from specific dose levels onward
- Adequate organ function with specified lab values
- Women of childbearing potential must have negative pregnancy test
- Agreement to avoid pregnancy or impregnating a partner during study and for 6 months after last dose
- For Substudy 4: AML diagnosis per WHO 2022 classification excluding acute promyelocytic leukemia
- Relapsed/refractory AML with specific blast counts and allowed use of hydroxyurea and leukapheresis
- Estimated life expectancy of at least 8 weeks
You will not qualify if you...
- Inability or unwillingness to give informed consent
- Age below 18 years
- Active or symptomatic brain metastases beyond specified stabilization criteria
- Poor performance status beyond ECOG 1 (or 2 for Substudy 4)
- Inadequate organ function outside specified lab value ranges
- Pregnant or breastfeeding women
- Failure to comply with contraception requirements
- Prior treatment with study drugs outside allowed settings
- Concurrent participation in another investigational study
- Uncontrolled infections or medical conditions that could interfere with study participation
- Acute promyelocytic leukemia diagnosis
- Blast counts above allowed thresholds prior to treatment start
- Use of prohibited medications during study period
- Any condition that investigator judges would make participation unsafe or not in patient's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive BAL0891 alone or in combination with chemotherapy or tislelizumab. BAL0891 is administered intravenously on Day 1 and Day 8 every 3 weeks, with alternative dosing schedules possible. Dose escalation is used to find the maximum tolerated dose or recommended Phase 2 dose.
Dosing visits on Day 1 and Day 8 every 3 weeks, with additional visits depending on dosing regimen and cohort
Duration - Up to 2 years after first dose
Participants are monitored for safety, adverse events, and overall response after treatment ends.
Visits every 3 months (±14 days) for up to 2 years
Trial Site Locations
Total: 15 locations
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
University of Miami Health System
Coral Gables, Florida, United States, 33146
Actively Recruiting
3
Winship Cancer Institute / Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Weill Cornell Medicine- NewYork-Presbyterian Hospital
New York, New York, United States, 10021
Actively Recruiting
6
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
7
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Active, Not Recruiting
8
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Withdrawn
9
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
11
Asan Medical Center
Seoul, South Korea
Actively Recruiting
12
Korean University Anam Hospital
Seoul, South Korea
Actively Recruiting
13
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
14
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
15
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
Research Team
S
SillaJen Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here