Purpose of this Study
This study has two parts. In the first part, researchers will test different doses of the study drug BBO-11818, alone and with other cancer treatments, to find a safe and effective dose. In the second part, more participants with specific types of cancer and KRAS mutations will receive BBO-11818 either by itself or with other medicines. Researchers will study its safety, effectiveness, and side effects.
Who Can Participate?
Eligibility
Participants may be able to join if they are adults with advanced cancer that cannot be removed with surgery or has spread to other parts of the body. They must have measurable tumors, be expected to live at least 12 more weeks, and be willing to complete study visits and procedures. Those with tumors that cannot be treated with curative radiation therapy may also be eligible.
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
This study is testing a new drug called BBO-11818 in people with advanced solid tumors. Researchers want to find the safest and most effective dose when the drug is used alone or combined with standard cancer treatments. They will also study its benefits, risks, and side effects in people with cancers that have specific KRAS mutations.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects with Advanced KRAS Mutant Cancers
Principal Investigator
Laura
Alder
Protocol Number
PRO00119798
NCT ID
NCT06917079
Phase
I
Enrollment Status
Open to Enrollment