POTENTIATE

Purpose of this Study

We are doing this study to find out if an experimental drug called BBI-355 (the study drug) is a safe and effective option for people with solid tumor forms of cancer. We also want to know the best dosing strategy for the drug. We plan to have later parts of this study that will look at how the study drug works when it is given with other cancer drugs.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with a solid tumor form of cancer
  • Have locally advanced or non-resectable (cannot be removed by surgery) disease
For more information about who can join this study, please contact the study team at hollie.watson@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join the study and are found to be eligible for dosing, you will take the study drug for a series of 28-day periods called "cycles." There are 5 possible dosing schedules to which you will be assigned. Your possible assignments will be:
  • 1) Every other day: dosing of the study drug on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27 of each 28-day cycle
  • 2) 2 days on/5 days off: daily doses of the study drug for 2 days in a row followed by 5 days of no dosing, which is repeated weekly during each cycle
  • 3) Days 1 and 3 dosing: once daily dosing of the study drug on days 1 and 3 each week, which is repeated weekly during each cycle
  • 4) 3 days on/11 days off: daily doses of the study drug for three days in a row followed by eleven days of no dosing, which is repeated weekly during each cycle
  • 5) Once per week: 1 dose of the study drug per week
The study drug is a table that you take by mouth.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

Principal Investigator

Niharika
Mettu

Protocol Number

PRO00116993

NCT ID

NCT05827614

Phase

I/II

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov