RECRUITING

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

Conditions

Advanced Solid Tumor TNBC - Triple-Negative Breast Cancer Gastric Cancer Leukemia Acute Myeloid Leukemia (AML)carcinoma carboplatin paclitaxel

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 carboplatin 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.

Official Title

A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia

Quick Facts

Study Start:2022-12-14

Study Completion:2026-03-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05768932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

SillaJen Inc.

CONTACT

02-368-2600

patient_inquiry@sillajen.com

Principal Investigator

SillaJen Inc.

STUDY_DIRECTOR

SillaJen, Inc.

Study Locations (Sites)

Yale New Haven Hospital

New Haven, Connecticut, 06510

United States

University of Miami Health System

Coral Gables, Florida, 33146

United States

Moffit Cancer Center

Tampa, Florida, 33612

United States

Montefiore Medical Center

Bronx, New York, 10461

United States

OHSU Knight Cancer Institute

Portland, Oregon, 97239

United States

Mary Crowley Cancer Research

Dallas, Texas, 75230

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: SillaJen, Inc.

SillaJen Inc., STUDY_DIRECTOR, SillaJen, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-14

Study Completion Date2026-03-24

Study Record Updates

Study Start Date2022-12-14

Study Completion Date2026-03-24

Terms related to this study

Keywords Provided by Researchers

carcinoma
carboplatin
paclitaxel

Additional Relevant MeSH Terms

Advanced Solid Tumor
TNBC - Triple-Negative Breast Cancer
Gastric Cancer
Leukemia Acute Myeloid Leukemia (AML)