Clinical trial for Advanced Solid Tumor
Official title BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT05768932
What this study is testing
What is BAL0891?
an investigational IV medicine being studied as a potential treatment for advanced solid tumors is designed to inhibit threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK1)
Also referred to as TTK‑CS‑101.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how safe and tolerable BAL0891 is, find the best dose, and look for early signs it might shrink tumors.
- Who it's for
- Adults who have advanced solid cancers (such as triple‑negative breast cancer or gastric cancer) or whose acute myeloid leukemia has come back or not responded to treatment.
- What's involved
- Participants receive an IV infusion of BAL0891, sometimes together with tislelizumab or paclitaxel, while doctors monitor side effects and do regular scans and lab tests.
- Time commitment
- The trial runs for several months with multiple clinic visits for dosing, safety checks, and imaging assessments.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1.1. Substudy 1, 2, 3 and Dose expansion Each patient must meet all the following .
- Informed consent signed by the patient prior to any study-related procedure indicating that they understand the purpose of, and procedures required...
- Male or female aged ≥18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
- Patients with incurable advanced/metastatic solid tumor disease refractory to or intolerant of existing therapy known to provide clinical benefit for...
- Patients enrolled in Dose Expansion only
See the full eligibility criteria
- 1.1. Substudy 1, 2, 3 and Dose expansion Each patient must meet all the following .
- 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.
- Male or female aged ≥18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
- Patients with incurable advanced/metastatic solid tumor disease refractory to or intolerant of existing therapy known to provide clinical benefit for their condition.
- Patients enrolled in Dose Expansion only
- TNBC cohorts i. Must have histologically confirmed breast adenocarcinoma that is unresectable, loco-regional, or metastatic. ii.
- 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)
- 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...
- 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.
- 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...
- Patients enrolled in Dose Expansion only, patient must have undergone a minimum of 1 prior systemic regimen for advanced or metastatic disease.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0or-1
- 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...
- Hemoglobin ≥ 9 g/dL (criterion must be met without erythropoietin dependency and without packed red blood cell transfusion within the last 4 weeks)
- 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
- Platelets ≥ 100 × 109/L
- Total bilirubin ≤ 1.5 × ULN
- 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...
- Albumin ≥ 2.8 g/dL
- 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)
- For women of childbearing potential, negative serum human chorionic gonadotropin (hCG)
- 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...
- 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.
- Male or female aged ≥18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
- Estimated life expectancy of at least 8 weeks
- 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)...
- 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...
- WBC, peripheral blood leukocyte count≤ 25,000/µL and blast count ≤ 25,000/µL prior to initiation of therapy
- 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.
- 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.
- Leukapheresis is allowed to maintain blast count ≤25,000/µL
- 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)
- Total bilirubin ≤ 1.5 × ULN (unless considered due to leukemic organ involvement), or, Direct bilirubin ≤ ULN for people with total bilirubin levels \> 1.5 ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) baseline levels ≤ 3.0 × ULN
- Albumin ≥ 2.5 g/dL
- 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
- 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
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- New Haven, Connecticut, United States
- Coral Gables, Florida, United States
- Atlanta, Georgia, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- The Bronx, New York, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Haven, Connecticut, United States; Coral Gables, Florida, United States; Atlanta, Georgia, United States; Ann Arbor, Michigan, United States; New York, New York, United States; The Bronx, New York, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.