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

ConditionsAdvanced Solid TumorTNBC - Triple-Negative Breast CancerGastric CancerLeukemia Acute Myeloid Leukemia (AML)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSillaJen, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

260 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1: Substudy 1, Dose-escalation substudy of BAL0891 monotherapyExperimental treatment 1 intervention
Group B: Part 1: Substudy 2, Dose-escalation substudy of BAL0891 in combination with tislelizumabExperimental treatment 2 interventions
Group C: Part 1: Substudy 3, Dose-escalation substudy of BAL0891 in combination with paclitaxelExperimental treatment 2 interventions
Group D: Part 2 : Dose expansion, cohorts 1 TNBC (BAL0891 monotherapy)Experimental treatment 1 intervention
Group E: Part 2 : Dose expansion, cohorts 2 GC (BAL0891 monotherapy)Experimental treatment 1 intervention
Group F: Part 2 : Dose expansion, cohorts 3 TNBC (BAL0891 + Paclitaxel)Experimental treatment 2 interventions
Group G: Part 2 : Dose expansion, cohorts 4 GC (BAL0891 + Paclitaxel)Experimental treatment 2 interventions
Group H: Part 1: Substudy 4, Dose-escalation substudy of BAL0891 monotherapy in r/r AMLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Safety is collected through summaries of AE(Adverse Event)s, safety laboratory evaluations, PK evaluations, physical examinations, vital signs, and ECGs using CTCAE v5.0.

Time frame
After first dose, up to 2 years
2

Part 1: Number of Participants With the DLT (Dose-limiting toxicity)s as a Measure of maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)

DLTs are collected through BLRM-EWOC.

Time frame
After first dose and within 7 days of End of Treatment, up to 2 years
3

Part 2: Overall response rate (ORR) for all subjects

The proportion of patients with confirmed complete response (CR) or partial response (PR) by RECIST 1.1/iRECIST (substudy 2 only) during the dose expansion phase.

Time frame
Every 3 months (±14 days) after first dose, up to 2 years

Secondary outcomes

1

Part 1: Pharmacokinetics (PK) parameters for all subjects

The area under the plasma concentration-time curve (AUC) by PK Sampling

Time frame
Within 7 days of End of Treatment, up to 2 years
2

Part 1: Absolute neutrophil count (ANC) for all subjects

Duration of neutropenia by PD Sampling

Time frame
Within 7 days of End of Treatment, up to 2 years
3

Part 1, 2: Overall response rate (ORR) for all subjects

The proportion of patients with confirmed complete response (CR) or partial response (PR) by RECIST 1.1

Time frame
Every 3 months (±14 days) after first dose, up to 2 years
4

Part 1, 2: Disease control rate (DCR) for all subjects

The proportion of patients with confirmed CR, PR or stable disease (SD) by RECIST 1.1

Time frame
Within 7 days of End of Treatment, up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SillaJen, Inc.

Lead sponsor

Source ClinicalTrials.gov
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