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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
SillaJen, Inc.
Study ID
NCT05768932
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BAL0891 — DRUG
    BAL0891 is a dual inhibitor of threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK1)
  • Tislelizumab — COMBINATION_PRODUCT
    Tislelizumab a humanized IgG4 anti-PD-1 monoclonal antibody
  • Paclitaxel — COMBINATION_PRODUCT
    Paclitaxel is a natural product with antitumor activity

Study Details

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.

Key Dates

Start date
Dec 14, 2022
Status verified
Mar 2026
Primary completion
Dec 24, 2026
Completion
Dec 24, 2026

Study Design

Enrollment
260 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Substudy 1, Dose-escalation substudy of BAL0891 monotherapy
    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).
  • Experimental: Part 1: Substudy 2, Dose-escalation substudy of BAL0891 in combination with tislelizumab
    Increasing doses of BAL0891 will be administrated IV on D1 and D15 with tislelizumab administration on D8 Q3W. The starting dose of BAL0891 for combination will be at approximately 50% of the BAL0891 monotherapy MTD determined in Substudy 1 and tislelizumab dose will be 200mg IV.
  • Experimental: Part 1: Substudy 3, Dose-escalation substudy of BAL0891 in combination with paclitaxel
    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.
  • Experimental: Part 2 : Dose expansion, cohorts 1 TNBC (BAL0891 monotherapy)
    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.
  • Experimental: Part 2 : Dose expansion, cohorts 2 GC (BAL0891 monotherapy)
    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.
  • Experimental: Part 2 : Dose expansion, cohorts 3 TNBC (BAL0891 + Paclitaxel)
    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.
  • Experimental: Part 2 : Dose expansion, cohorts 4 GC (BAL0891 + Paclitaxel)
    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.
  • Experimental: Part 1: Substudy 4, Dose-escalation substudy of BAL0891 monotherapy in r/r AML
    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.

Primary Outcome Measure

Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: After first dose, up to 2 years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510
Yale New Haven Hospital
University of Miami Health SystemCoral GablesFlorida33146
University of Miami Health System
Winship Cancer Institute / Emory UniversityAtlantaGeorgia30322
Winship Cancer Institute / Emory University
University of MichiganAnn ArborMichigan48109
University of Michigan
Weill Cornell Medicine- NewYork-Presbyterian HospitalNew YorkNew York10021
Weill Cornell Medicine- NewYork-Presbyterian Hospital
Montefiore Medical CenterThe BronxNew York10461
Montefiore Medical Center
OHSU Knight Cancer InstitutePortlandOregon97239-
Mary Crowley Cancer ResearchDallasTexas75230-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
The University of Texas MD Anderson Cancer Center

Find similar trials in New Haven, CT

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Yale New Haven Hospital· New Haven, CTUniversity of Miami Health System· Coral Gables, FLWinship Cancer Institute / Emory University· Atlanta, GAUniversity of Michigan· Ann Arbor, MIWeill Cornell Medicine- NewYork-Presbyterian Hospital· New York, NYMontefiore Medical Center· The Bronx, NY

Related Studies