Actively Recruiting
BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia
Led by SillaJen, Inc. · Updated on 2026-03-27
260
Participants Needed
15
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 indicating understanding and willingness to participate
- Male or female aged 18 years or older (or 19 per local guidelines) at screening
- Patients with incurable advanced or metastatic solid tumors refractory or intolerant to existing therapies
- For dose expansion TNBC cohorts: histologically confirmed unresectable or metastatic triple-negative breast cancer with progression after anthracycline and/or taxane therapy
- For dose expansion GC cohort: histologically or cytologically confirmed gastric or gastroesophageal adenocarcinoma with progression after platinum/fluoropyrimidine therapy
- HER2/neu status documented for GC patients; HER2 positive patients must have progressed on or be intolerant to HER2 inhibitors
- Received 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 if applicable
- Minimum one prior systemic regimen for advanced/metastatic disease for dose expansion patients
- ECOG performance status 0 or 1 (0-2 for Substudy 4)
- Measurable tumor disease per RECIST 1.1 from DL1.4 of Substudy 1 onwards and for Substudies 2, 3, and dose expansion
- Adequate organ function based on laboratory values including hemoglobin, ANC, platelets, bilirubin, liver enzymes, albumin, and kidney function
- Negative pregnancy test for women of childbearing potential
- Agree to use effective contraception during study and for 6 months after last dose
You will not qualify if you...
- Acute promyelocytic leukemia subtype excluded
- Patients with CNS metastases must have stable disease with resolved neurological symptoms and stable or no steroid use
- Prior anti-leukemic treatments other than hydroxyurea or leukapheresis not allowed during initial AML treatment cycle
- White blood cell and blast counts above specified limits at therapy start
- Inadequate organ function per specified laboratory criteria
- Inability or unwillingness to comply with contraception requirements during study and 6 months after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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