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NOTCH Pathway Inhibitor
CB-103 + Venetoclax for Advanced Cancer
Phase 1 & 2
Recruiting
Led By Glenn Hanna, MD
Research Sponsored by Glenn J. Hanna
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Summary
This trial is testing a combination of drugs to treat advanced ACC tumors and improve survival.
Who is the study for?
This trial is for adults with advanced adenoid cystic carcinoma (ACC) that's NOTCH active. They should have good organ function, no severe illnesses, and agree to use effective contraception. Treatment-naïve patients or those who've had certain therapies can join specific cohorts.
What is being tested?
The study tests CB-103 alone or combined with Venetoclax in treating ACC by inhibiting the NOTCH pathway and blocking BCL-2 protein. Lenvatinib targets VEGFR pathways. The aim is to slow tumor growth and improve survival.
What are the potential side effects?
Potential side effects may include digestive issues, liver enzyme changes, fatigue, blood cell count variations, and possibly increased risk of infection due to immune system impact from these oral medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Survival (PFS) of Cohort 1
Progression-Free Survival (PFS) of Cohort 2
Secondary study objectives
Duration of Overall Response (DOR)
Number of Participants with treatment related Adverse Events per CTCAE 5.0
Overall Response Rate (ORR)
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Experimental: Cohort 2B- Lenvatinib + CB-103Experimental Treatment2 Interventions
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.
Group II: Experimental: Cohort 2A- Lenvatinib + CB-103Experimental Treatment2 Interventions
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.
Group III: Experimental: Cohort 1B - CB-103 + AbemaciclibExperimental Treatment2 Interventions
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.
Group IV: Experimental: Cohort 1A - CB-103 + AbemaciclibExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1800
Lenvatinib
2017
Completed Phase 4
~2040
Find a Location
Who is running the clinical trial?
Cellestia Biotech AGIndustry Sponsor
2 Previous Clinical Trials
81 Total Patients Enrolled
Adenoid Cystic Carcinoma Research FoundationOTHER
6 Previous Clinical Trials
185 Total Patients Enrolled
Glenn J. HannaLead Sponsor
3 Previous Clinical Trials
86 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I agree to use birth control during the study.I currently have an active infection (bacterial, fungal, or viral).I have finished radiotherapy and recovered from its immediate side effects.I have another cancer that won't affect this treatment's safety or results.I have brain metastases or carcinomatous meningitis that are untreated or causing symptoms.I am 18 years old or older.I am a woman who can have children and have a negative pregnancy test taken within the last week.I have not had major surgery in the last 14 days.I am on blood thinners that need regular INR checks.I have a confirmed diagnosis of advanced or incurable adenoid cystic carcinoma.I can swallow pills.I have a digestive issue that affects how my body absorbs medication.I have had treatment for brain or CNS cancer spread and meet certain conditions.I have not had VEGFR TKI therapy but may have had chemotherapy for curative purposes.I have secured a way to pay for or obtain Lenvatinib for the study's duration.I have previously received specific cancer treatments targeting blood vessel growth.My organ and bone marrow functions are within normal ranges.I have recovered from my last chemotherapy and followed the waiting period.My cancer has a NOTCH mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Cohort 2B- Lenvatinib + CB-103
- Group 2: Experimental: Cohort 1A - CB-103 + Abemaciclib
- Group 3: Experimental: Cohort 1B - CB-103 + Abemaciclib
- Group 4: Experimental: Cohort 2A- Lenvatinib + CB-103
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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