CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Glenn J. Hanna
Study ID
NCT05774899
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • CB-103 — DRUG
    First-in-class pan-NOTCH inhibitor, capsule taken orally.
  • Abemaciclib — DRUG
    CDK4/6 inhibitor, tablet taken orally.
  • Lenvatinib — DRUG
    Per standard care, capsule taken orally.

Study Details

The goal of this study is to treat patients with NOTCH active advanced adenoid cystic carcinoma (ACC) tumors with a combination or two different oral medications to slow tumor growth and improve survival outcomes. The names of the study drugs involved in this study are: * CB-103 (an oral NOTCH pathway inhibitor) * Abemaciclib (CDK4/6 inhibitor) * Lenvatinib (a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI))

Key Dates

Start date
Jun 1, 2023
Status verified
Jun 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Cohort 1A - CB-103 + Abemaciclib
    A modified 3+3 dose escalation design will be used. 3-9 participants will receive: * Standard of care Abemaciclib. * Cycle 1 - End of Treatment --Days 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week. * A safety review will be performed by primary investigation after completion of the ramp-up phase.
  • Experimental: Experimental: Cohort 1B - CB-103 + Abemaciclib
    Participants will receive: * Cycle 1 - End of Treatment --Days 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week and predetermined dose of Abemaciclib 1x daily. * Therapy will continue until disease progression, therapy intolerance, or participant withdrawal. * End of Treatment (EOT) visit within 30 days of last administration of study treatments.
  • Experimental: Experimental: Cohort 2A- Lenvatinib + CB-103
    A modified 3+3 dose escalation design will be used. 3-9 participants will receive: * Standard of care VEGFR TKI. * Cycle 1 - End of Treatment --Days 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week. * A safety review will be performed by primary investigation after completion of the ramp-up phase.
  • Experimental: Experimental: Cohort 2B- Lenvatinib + CB-103
    Participants will receive: * Continue standard of care VEGFR TKI at prior dose and schedule. * Cycle 1 - End of Treatment --Day 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week. * Therapy will continue until disease progression, therapy intolerance, or participant withdrawal. * End of Treatment (EOT) visit within 30 days of last administration of study treatments.

Primary Outcome Measure

Progression-Free Survival (PFS) of Cohort 1 [ Time Frame: At 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Glenn Hanna, MD
[email protected]
617-632-3090
Glenn Hanna, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dana Farber Cancer Institute· Boston, MA

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