> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/bal0891-in-patients-with-advanced-solid-tumors-or-relapsed-6555e1cd-a823-4416-bc7a-0e3e9aae92d3 > Record changed: 2026-10-13 # BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia NCT05768932 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) Participants 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) Lead sponsor SillaJen, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) Start date 2022-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) Number of sites 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Short title** BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Official title** A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy or Tislelizumab in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Dates **Completion date** 2026-12-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **First posted** 2023-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Registry last updated** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Primary completion date** 2026-12-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Start date** 2022-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Size and sites **Participants** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Planned participants** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Number of sites** 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Lead sponsor** SillaJen, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Identifiers **Registry ID** NCT05768932 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **ClinicalTrials.gov ID** NCT05768932 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Outcomes ### Primary outcomes 1. Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability Timeframe: After 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. 2. 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) Timeframe: After first dose and within 7 days of End of Treatment, up to 2 years DLTs are collected through BLRM-EWOC. 3. Part 2: Overall response rate (ORR) for all subjects Timeframe: Every 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. ### Secondary outcomes 1. Part 1: Pharmacokinetics (PK) parameters for all subjects Timeframe: Within 7 days of End of Treatment, up to 2 years The area under the plasma concentration-time curve (AUC) by PK Sampling 2. Part 1: Absolute neutrophil count (ANC) for all subjects Timeframe: Within 7 days of End of Treatment, up to 2 years Duration of neutropenia by PD Sampling 3. Part 1, 2: Overall response rate (ORR) for all subjects Timeframe: Every 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 4. Part 1, 2: Disease control rate (DCR) for all subjects Timeframe: Within 7 days of End of Treatment, up to 2 years The proportion of patients with confirmed CR, PR or stable disease (SD) by RECIST 1.1 5. Part 1, 2: Progression-free survival (PFS) for all subjects Timeframe: Within 7 days of End of Treatment, up to 2 years Measured from patient enrollment to disease progression date 6. Part 1, 2: Overall survival (OS) for all subjects Timeframe: Within 7 days of End of Treatment, up to 2 years Measured from from patient enrollment to time of death 7. Part 2: Safety evaluations for all subjects Timeframe: After first dose, up to 2 years Safety evaluations is focusing on key clinical evlauations such treatment-emergent adverse events (TEAE) using CTCAE v5.0. 8. Part 1: Efficacy Endpoints CR + CRh Rate (Substudy 4) Timeframe: Up to 2 years Proportion of patients achieving Complete Remission (CR) or CR with partial hematologic recovery (CRh) per European LeukemiaNet (ELN) 2022 guidelines. 9. Part 1: Efficacy Endpoints Duration of Remission (DoR) (Substudy 4) Timeframe: Up to 2 years Time from first documented CR/CRh until relapse or death. 10. Part 1: Efficacy Endpoints Transfusion Independence (TI) (Substudy 4) Timeframe: Up to 2 years Proportion of patients achieving red blood cell (RBC) and platelet transfusion independence for ≥56 consecutive days. 11. Part 1: Efficacy Endpoints CR/CRh without Measurable Residual Disease (MRD) (Substudy 4) Timeframe: Up to 2 years Proportion of patients achieving CR/CRh and MRD negativity. 12. Part 1: Efficacy Endpoints Composite Complete Remission (CRc) Rate (Substudy 4) Timeframe: Up to 2 years Proportion of patients achieving CR, CRh, or CR with incomplete hematologic recovery (CRi). 13. Part 1: Efficacy Endpoints Overall Response Rate (ORR) (Substudy 4) Timeframe: Up to 2 years Proportion of patients achieving CR, CRh, CRi, or Partial Remission (PR). 14. Part 1: Efficacy Endpoints Overall Survival (OS) (Substudy 4) Timeframe: Up to 2 years Time from first dose of BAL0891 to death from any cause. 15. Part 1: Efficacy Endpoints Event-Free Survival (EFS) (Substudy 4) Timeframe: Up to 2 years Time from first dose of BAL0891 to disease progression, relapse, or death. 16. Part 1: Efficacy Endpoints Time to Response (TTR) (Substudy 4) Timeframe: Up to 2 years Time from first dose of BAL0891 to first documented response. 17. Part 1: QTcF Interval Analysis Timeframe: From first dose to 30 days post last dose Analysis of QTcF interval data collected during BAL0891 monotherapy and the relationship between BAL0891 exposure and QTcF interval prolongation. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 1.1\. Inclusion criteria: Substudy 1, 2, 3 and Dose expansion Each patient must meet all the following inclusion 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. Note: Patients with non-CNS tumors participating during dose escalation may have inactive CNS metastasis, defined as 4 weeks after either brain metastasis resection or radiation, and a) all residual neurological symptoms resolved to grade ≤ 2; b) on stable doses of dexamethasone, if applicable; and c) follow-up imaging shows no new lesions appearing. 4. Patients enrolled in Dose Expansion only • TNBC cohorts i. Must have histologically confirmed breast adenocarcinoma that is unresectable, loco-regional, or metastatic. ii. Must have source data documented pathologically confirmed triple negative breast cancer, defined as both of the following. 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. iv. 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. At time of enrolment, patients must have progressed on, be intolerant of, or be ineligible for, all available standard of care therapies with proven benefit. • GC cohort i. Must have a histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma. ii. 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. At time of enrolment, patients must have progressed on, be intolerant of, or be ineligible for, all available standard of care therapies with proven benefit. iii. 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. At time of enrolment, patients must have progressed on, be intolerant of, or be ineligible for, all available standard of care therapies with proven benefit. iv. Subjects must/should have received no more than 3 lines of prior therapy for the advanced disease (if a subject progressed within 6 months of completing adjuvant therapy, this would count as a prior line of therapy). 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\. Inclusion criteria: Substudy 4 Each patient must meet all the following inclusion 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. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2. 4. Estimated life expectancy of at least 8 weeks 5. AML either de novo or secondary as any subtype diagnosed according to the WHO 2022 classification system \[except acute promyelocytic leukemia (APL)\] who either: Relapse/refractory (R/R) acute myeloid leukemia (AML) defined as those who have also failed or are not appropriate for any approved standard-of-care (SOC) therapies, or hematopoietic stem cell transplant (HSCT) with reappearance of ≥ 5% blasts in the bone marrow. 6. Relapsed AML is defined as having 5% or more leukemic blasts in the bone marrow, reappearance of leukemic blasts in peripheral blood (in at least two peripheral blood samples taken at least one week apart), or the development of new extramedullary disease. 7. WBC, peripheral blood leukocyte count≤ 25,000/µL and blast count ≤ 25,000/µL prior to initiation of therapy 1. Hydroxyurea is allowed during screening and prior to day 1 of study treatment to keep the blast count ≤25,000/µL; hydroxyurea is to be ceased 24 hours prior to study therapy. 2. Hydroxyurea may be used for up to 28 days in the initial treatment cycle if needed, to keep the white blood cell (WBC) count ≤25,000/µL. However, no other anti-leukemic treatments, apart from the study drug, are allowed during this period. 3. Leukapheresis is allowed to maintain blast count ≤25,000/µL 8. Adequate organ functions as indicated by the following Screening visit local laboratory values: 1. CLCR ≥ 60 mL/min (as calculated by the Cockcroft-Gault formula), or eGFR ≥ 60 mL/min/1.73 m² (MDRD equation or CKD-EPI equation) 2. Total bilirubin ≤ 1.5 × ULN (unless considered due to leukemic organ involvement), or, Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) baseline levels ≤ 3.0 × ULN 4. Albumin ≥ 2.5 g/dL 5. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 6. Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 9. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Sites - Yale New Haven HospitalNew Haven, United StatesRecruiting - University of Miami Health SystemCoral Gables, United StatesRecruiting - Winship Cancer Institute / Emory UniversityAtlanta, United StatesRecruiting - University of MichiganAnn Arbor, United StatesRecruiting - New York Medicine-New York-Presbyterian HospitalNew York, United StatesRecruiting - Montefiore Medical Center - Montefiore HospitalNew York, United StatesRecruiting - Montefiore Medical CenterThe Bronx, United StatesRecruiting - OHSU Knight Cancer InstitutePortland, United StatesCompleted - Mary Crowley Cancer ResearchDallas, United StatesCompleted - Baylor University Medical CenterDallas, United StatesRecruiting - The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - The Catholic University of Korea, Seoul St. Mary's HospitalSeoul, South KoreaRecruiting - Asan Medical CenterSeoul, South KoreaRecruiting - Korean University Anam HospitalSeoul, South KoreaRecruiting - Samsung Medical CenterSeoul, South KoreaRecruiting - Seoul National University HospitalSeoul, South KoreaRecruiting - Severance Hospital, Yonsei University Health SystemSeoul, South KoreaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05768932) ## Related records ### Drugs (2) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Tislelizumab](https://trialight.com/data/asset/tislelizumab-70601caf-7705-4f05-b211-e6a4d4556fe3.md) ### Lead sponsors (1) - [SillaJen, Inc.](https://trialight.com/data/company/sillajen-inc-d0b7fac2-037d-4971-b946-02aae46e8828.md) ### Conditions (6) - [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) - [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Leukemia](https://trialight.com/data/condition/leukemia-519aefcd-8521-5941-851b-5b77ca925ca5.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) ### Targets (16) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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