BAL0891 + Chemotherapy for Solid Tumors
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: SillaJen, Inc.
Disqualifiers: Acute promyelocytic leukemia, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This trial tests a new drug, BAL0891, given to patients with severe cancer. It aims to find a safe and effective amount, both alone and with other cancer treatments. The goal is to determine the best amount that patients can handle.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, hydroxyurea is allowed during screening and the initial treatment cycle for certain patients, but no other anti-leukemic treatments are allowed during this period.
What data supports the effectiveness of the drug BAL0891 for solid tumors?
What safety data exists for treatments similar to BAL0891 in humans?
Studies on similar treatments, like NMS-1286937 and BI 2536, show that the main safety concerns are blood-related issues, such as low platelet counts (thrombocytopenia) and low white blood cell counts (neutropenia). These treatments have been tested in people with advanced solid tumors, and while some patients experienced these side effects, they were generally manageable.36789
What makes the drug BAL0891 unique for treating solid tumors?
BAL0891 is unique because it targets Polo-like kinase 1 (Plk1), a protein that plays a crucial role in cell division and is often overexpressed in cancer cells, making it a promising target for cancer treatment. This drug works by interfering with the cell cycle, leading to cancer cell death, and is being studied in combination with chemotherapy to enhance its effectiveness.310111213
Research Team
SI
SillaJen Inc.
Principal Investigator
SillaJen, Inc.
Eligibility Criteria
Adults with advanced solid tumors that are resistant or intolerant to existing treatments may join this trial. They should be in good physical condition (ECOG PS 0 or 1), have normal bilirubin levels, and adequate organ function including blood counts and liver enzymes. Women must not be pregnant, and all participants must agree to use contraception during the study.Inclusion Criteria
I am 18 years old or older.
For women of child-bearing potential, negative serum human chorionic gonadotropin (hCG)
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
See 5 more
Exclusion Criteria
Receipt of treatment before the first dose of study drug within specified intervals
I haven't fully recovered from major surgery within the last 4 weeks.
I haven't taken steroids or immunosuppressants recently.
See 13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Participants receive increasing doses of BAL0891 as monotherapy or in combination with chemotherapy to determine safety and tolerability.
Varies by cohort, up to 2 years
Every 3 weeks for monotherapy, every 4 weeks for combination therapy
Dose Expansion
Further evaluation of the preliminary anti-tumor activity, safety, and tolerability at the recommended Phase 2 dose (RP2D) in specific cancer cohorts.
Up to 2 years
Every 3 months for assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 2 years
Treatment Details
Interventions
- BAL0891 (Other)
Trial OverviewThe trial is testing BAL0891 alone and alongside chemotherapy drugs carboplatin or paclitaxel. It's an open-label Phase 1 study where doses of BAL0891 will gradually increase to assess safety and tolerability in patients with various types of advanced solid tumors.
Participant Groups
8Treatment groups
Experimental Treatment
Group I: Part 2 : Dose expansion, cohorts 4 GC (BAL0891 + Paclitaxel)Experimental Treatment2 Interventions
BAL0891 will be administered intravenously on D1 and D15, Q4W for cohorts 4. The investigation will focus on the RP2D determined during the dose escalation phase of the study. Specifically, cohorts 4 will utilize the RP2D established in substudy 3 of the dose escalation phase.
Group II: Part 2 : Dose expansion, cohorts 3 TNBC (BAL0891 + Paclitaxel)Experimental Treatment2 Interventions
BAL0891 will be administered intravenously on D1 and D15, Q4W for cohorts 3 . The investigation will focus on the RP2D determined during the dose escalation phase of the study. Specifically, cohorts 3 will utilize the RP2D established in substudy 3 of the dose escalation phase.
Group III: Part 2 : Dose expansion, cohorts 2 GC (BAL0891 monotherapy)Experimental Treatment1 Intervention
BAL0891 will be administered intravenously on D1 and D8, Q3W for cohorts 2. The investigation will focus on the RP2D determined during the dose escalation phase of the study. Specifically, cohorts 2 will utilize the RP2D established in substudy 1 of the dose escalation phase.
Group IV: Part 2 : Dose expansion, cohorts 1 TNBC (BAL0891 monotherapy)Experimental Treatment1 Intervention
BAL0891 will be administered intravenously on D1 and D8, Q3W for cohorts 1. The investigation will focus on the RP2D determined during the dose escalation phase of the study. Specifically, cohorts 1 will utilize the RP2D established in substudy 1 of the dose escalation phase.
Group V: Part 1: Substudy 4, Dose-escalation substudy of BAL0891 monotherapy in r/r AMLExperimental Treatment1 Intervention
BAL0891 will be administered intravenously on Day 1 and Day 8 every three weeks (Regimen A). Dose exploration will proceed until the highest planned dose level (DL) is determined to be safe and tolerable, or the MTD/RP2D is identified.
Group VI: Part 1: Substudy 3, Dose-escalation substudy of BAL0891 in combination with paclitaxelExperimental Treatment2 Interventions
Paclitaxel will be dosed at 70 mg/m2 on D1, D8, and D15 Q4W, with an option to use 80 mg/m2 (either instead of, or after exploring, 70 mg/m2) if the cumulative data collected at that time support a higher dose of paclitaxel.
Group VII: Part 1: Substudy 2, Dose-escalation substudy of BAL0891 in combination with carboplatinExperimental Treatment2 Interventions
Carboplatin will be dosed at AUC5 Q3W, with an option to use AUC6 (either instead of, or after exploring, AUC5) if the cumulative data collected at that time support a higher dose of carboplatin.
Group VIII: Part 1: Substudy 1, Dose-escalation substudy of BAL0891 monotherapyExperimental Treatment1 Intervention
Increasing doses of BAL0891 will be administered IV on D1 and D8 Q3W (Regimen A). BAL0891 will be investigated in a dose range of 5-480 mg with Regimen A. Optionally, and based on cumulative safety, PK, and PD data, BAL0891 may be administered on D1 Q3W (Regimen B), D1 and D15 Q4W (Regimen C), or on D1, D8, and D15 Q4W (Regimen D).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Site 537 Montefiore Medical CenterBronx, NY
Site 540 OHSU Knight Cancer InstitutePortland, OR
Site 536 Mary Crowley Cancer ResearchDallas, TX
University of Miami Health SystemCoral Gables, FL
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
SillaJen, Inc.
Lead Sponsor
Trials
3
Patients Recruited
810+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase I trial of volasertib, a Polo-like kinase inhibitor, plus platinum agents in solid tumors: safety, pharmacokinetics and activity.Awada, A., Dumez, H., Aftimos, PG., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Polo-like kinase and its inhibitors: Ready for the match to start?Palmisiano, ND., Kasner, MT.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase I dose escalation study of NMS-1286937, an orally available Polo-Like Kinase 1 inhibitor, in patients with advanced or metastatic solid tumors.Weiss, GJ., Jameson, G., Von Hoff, DD., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Discovery of TAK-960: an orally available small molecule inhibitor of polo-like kinase 1 (PLK1).Nie, Z., Feher, V., Natala, S., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
An open-label, phase I study of the polo-like kinase-1 inhibitor, BI 2536, in patients with advanced solid tumors.Hofheinz, RD., Al-Batran, SE., Hochhaus, A., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase I dose escalation and pharmacokinetic study of BI 2536, a novel Polo-like kinase 1 inhibitor, in patients with advanced solid tumors.Mross, K., Frost, A., Steinbild, S., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The Plk1 inhibitor BI 2536 in patients with refractory or relapsed non-Hodgkin lymphoma: a phase I, open-label, single dose-escalation study.Vose, JM., Friedberg, JW., Waller, EK., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Polo-like kinase 1 inhibition in NSCLC: mechanism of action and emerging predictive biomarkers.Stratmann, JA., Sebastian, M.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Toxicity modelling of Plk1-targeted therapies in genetically engineered mice and cultured primary mammalian cells.Raab, M., Kappel, S., Krämer, A., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Polo-like kinase (PLK) inhibitors in preclinical and early clinical development in oncology.Schöffski, P.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Targeting Polo-Like Kinases: A Promising Therapeutic Approach for Cancer Treatment.Liu, X.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Developments of polo-like kinase 1 (Plk1) inhibitors as anti-cancer agents.Li, S., Zhang, Y., Xu, W.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
BI_2536--targeting the mitotic kinase Polo-like kinase 1 (Plk1).Wäsch, R., Hasskarl, J., Schnerch, D., et al.[2023]
References
Phase I trial of volasertib, a Polo-like kinase inhibitor, plus platinum agents in solid tumors: safety, pharmacokinetics and activity. [2023]
Polo-like kinase and its inhibitors: Ready for the match to start? [2023]
Phase I dose escalation study of NMS-1286937, an orally available Polo-Like Kinase 1 inhibitor, in patients with advanced or metastatic solid tumors. [2023]
Discovery of TAK-960: an orally available small molecule inhibitor of polo-like kinase 1 (PLK1). [2023]
An open-label, phase I study of the polo-like kinase-1 inhibitor, BI 2536, in patients with advanced solid tumors. [2023]
Phase I dose escalation and pharmacokinetic study of BI 2536, a novel Polo-like kinase 1 inhibitor, in patients with advanced solid tumors. [2023]
The Plk1 inhibitor BI 2536 in patients with refractory or relapsed non-Hodgkin lymphoma: a phase I, open-label, single dose-escalation study. [2023]
Polo-like kinase 1 inhibition in NSCLC: mechanism of action and emerging predictive biomarkers. [2020]
Toxicity modelling of Plk1-targeted therapies in genetically engineered mice and cultured primary mammalian cells. [2023]
Polo-like kinase (PLK) inhibitors in preclinical and early clinical development in oncology. [2023]
Targeting Polo-Like Kinases: A Promising Therapeutic Approach for Cancer Treatment. [2020]
Developments of polo-like kinase 1 (Plk1) inhibitors as anti-cancer agents. [2023]
BI_2536--targeting the mitotic kinase Polo-like kinase 1 (Plk1). [2023]