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New treatment option 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?
BAL0891 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
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
- 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.
- 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
Who can join
- 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. Note: Patients with non-CNS tumors participating...
- 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...
- 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. (Korea only, patients must have received the second line standard of care...
- 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...
- Adequate organ functions as indicated by the following Screening visit local laboratory values:
- 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. However, no other anti-leukemic treatments, apart from the study drug, are allowed...
- Leukapheresis is allowed to maintain blast count ≤25,000/µL
- Adequate organ functions as indicated by the following Screening visit local laboratory values:
- 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's taking place
- 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
- Portland, Oregon, 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 - 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?
Study sites include 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 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.