OncoMatch/Clinical Trials/NCT05768932
BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia
Is NCT05768932 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BAL0891 and Tislelizumab for advanced solid tumor.
Treatment: BAL0891 · Tislelizumab · Paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Triple-Negative Breast Cancer
Breast Carcinoma
Gastric Cancer
Acute Myeloid Leukemia
Biomarker criteria
Required: ESR1 negative (<1% of tumor cell nuclei are immunoreactive) (<1%)
Estrogen receptor (ER) negative: <1% of tumor cell nuclei are immunoreactive
Required: PR (PGR) negative (<1% of tumor cell nuclei are immunoreactive) (<1%)
Progesterone receptor (PgR) negative: <1% of tumor cell nuclei are immunoreactive
Required: HER2 (ERBB2) negative (IHC 0 or 1, FISH negative, or IHC 2 with FISH negative) (IHC 0 or 1, FISH negative, or IHC 2 with FISH negative)
HER2 negative as per American Society of Clinical Oncology/College of American Pathologists guidelines
Allowed: HER2 (ERBB2) overexpression or amplification (HER2/neu-positive)
Documentation of HER2/neu status. Patients who are HER2/neu-positive must be treated with a HER2/neu inhibitor, and subjects should have progressed on or be intolerant to the targeted therapy or subjects must have received other chemotherapy regimen if HER2/neu inhibitor was contraindicated or another available approved targeted agent unless the targeted agent was contraindicated.
Disease stage
Required: Stage IV, LOCO-REGIONAL
measurable tumor disease per Response Evaluation Criteria in Solid Tumors 1.1 criteria (RECIST 1.1), i.e., a minimum of one target lesion
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline
Must have progression on or after therapy containing anthracycline and/or a taxane. Subjects must have received anthracycline and/or a taxane based regimen or other chemotherapy / targeted therapy regimen if anthracycline or taxane was contraindicated or another available approved targeted agent was contraindicated.
Must have received: taxane
Must have progression on or after therapy containing anthracycline and/or a taxane. Subjects must have received anthracycline and/or a taxane based regimen or other chemotherapy / targeted therapy regimen if anthracycline or taxane was contraindicated or another available approved targeted agent was contraindicated.
Must have received: platinum-based chemotherapy
Must have progression on or after therapy containing platinum/fluoropyrimidine. Subjects must have received platinum-based chemotherapy or other chemotherapy regimen if platinum-based chemotherapy was contraindicated or another available approved targeted agent unless the targeted agent was contraindicated.
Must have received: fluoropyrimidine
Must have progression on or after therapy containing platinum/fluoropyrimidine. Subjects must have received platinum-based chemotherapy or other chemotherapy regimen if platinum-based chemotherapy was contraindicated or another available approved targeted agent unless the targeted agent was contraindicated.
Must have received: HER2-targeted therapy
Patients who are HER2/neu-positive must be treated with a HER2/neu inhibitor, and subjects should have progressed on or be intolerant to the targeted therapy or subjects must have received other chemotherapy regimen if HER2/neu inhibitor was contraindicated or another available approved targeted agent unless the targeted agent was contraindicated.
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dL (solid tumors); ANC ≥ 2.0 × 10^9/L (solid tumors); Platelets ≥ 100 × 10^9/L (solid tumors); Albumin ≥ 2.8 g/dL (solid tumors) or ≥ 2.5 g/dL (AML); WBC, peripheral blood leukocyte count ≤ 25,000/µL and blast count ≤ 25,000/µL prior to initiation of therapy (AML)
Kidney function
CLCR ≥ 50 mL/min (solid tumors) or ≥ 60 mL/min (AML), or eGFR ≥ 50 mL/min/1.73 m² (solid tumors) or ≥ 60 mL/min/1.73 m² (AML)
Liver function
Total bilirubin ≤ 1.5 × ULN; AST and ALT baseline levels ≤ 1.5 × ULN (solid tumors) or ≤ 3.0 × ULN (AML); option for AST/ALT ≤ 3.0 × ULN, or ≤ 5.0 × ULN for patients with liver metastasis, upon accumulating evidence for the absence of liver toxicity in biologically active DLs
Adequate organ functions as indicated by the following Screening visit local laboratory values
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale New Haven Hospital · New Haven, Connecticut
- University of Miami Health System · Coral Gables, Florida
- Winship Cancer Institute / Emory University · Atlanta, Georgia
- University of Michigan · Ann Arbor, Michigan
- Weill Cornell Medicine- NewYork-Presbyterian Hospital · New York, New York
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