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

Eligibility Criteria

• 1. Informed consent signed by the patient prior to any study-related procedure indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study.
• 2. Male or female aged ≥18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
• 3. Patients with incurable advanced/metastatic solid tumor disease refractory to or intolerant of existing therapy known to provide clinical benefit for their condition.
• 4. Patients enrolled in Dose Expansion only
• 1. Estrogen receptor (ER) and progesterone receptor (PgR) negative: \<1% of tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PgR (positive intrinsic controls)
• 2. Human epidermal growth factor receptor 2 (HER2) negative as per American Society of Clinical Oncology/College of American Pathologists guidelines
• * 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.
• 5. For patients enrolled in Substudy 3 or cohort 3 and 4, if a taxane (i.e., paclitaxel or docetaxel) was administered as part of the previous regimen, PD must have occurred \> 12 months from the end of the previous treatment. (Patients who received a taxane in previous treatments without reaching PD may enroll without the 12-month waiting period.)
• 6. Patients enrolled in Dose Expansion only, patient must have undergone a minimum of 1 prior systemic regimen for advanced or metastatic disease. (Korea only, patients must have received the second line standard of care treatment as per the regulations of the respective country. Patients who are unsuitable to receive the standard of care second line treatment will be eligible for enrollment)
• 7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0or-1
• 8. For patients enrolled from DL1.4 of Substudy 1 onwards and for all patients in Substudies 2 and 3 and all four dose expansion cohorts, measurable tumor disease per Response Evaluation Criteria in Solid Tumors 1.1 criteria (RECIST 1.1), i.e., a minimum of one target lesion.
• 9. Adequate organ functions as indicated by the following Screening visit local laboratory values:
• 1. Hemoglobin ≥ 9 g/dL (criterion must be met without erythropoietin dependency and without packed red blood cell transfusion within the last 4 weeks)
• 2. ANC ≥ 2.0 × 109/L; criterion must be met without growth factor (e.g., G-CSF, GM CSF, etc.) administration within the last 2 weeks
• 3. Platelets ≥ 100 × 109/L
• 4. Total bilirubin ≤ 1.5 × ULN
• 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) baseline levels ≤ 1.5 × ULN, with the 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
• 6. Albumin ≥ 2.8 g/dL
• 7. CLCR ≥ 50 mL/min (as calculated by the Cockcroft-Gault formula), or eGFR ≥ 50 mL/min/1.73 m² (MDRD equation or CKD-EPI equation)
• 8. For women of childbearing potential, negative serum human chorionic gonadotropin (hCG)
• 10. Men/women of child-producing/bearing potential must agree to: avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 6 months after the last dose of either investigational drug, and comply with the contraception requirements.
• 1.2.