Purpose of this Study
This study has two parts. In the first part, researchers test different dose levels of a new medicine called BBO 11818 to find the safest and best dose. Some people will receive BBO 11818 by itself, while others will receive it together with other cancer medicines. The treatment group depends on the type of cancer and the specific KRAS gene change a person has.
In the second part, more people will receive the dose that was found to be safe in the first part. Researchers will study BBO 11818 by itself and in combination with other treatments in different groups of patients. The goal is to learn more about how safe the medicine is, what side effects it may cause, and whether it can help slow or shrink cancers with specific KRAS gene changes.
Who Can Participate?
Eligibility
People may be able to join this study if they are adults and are willing to attend study visits and follow study instructions. They must have advanced cancer that has spread, cannot be removed with surgery, or cannot be fully treated with radiation. Participants must have at least one tumor that can be measured on scans so doctors can track changes during the study. They should also be expected to live for at least a few more months so researchers can safely study how the treatment affects their cancer.
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 medicine called BBO 11818 for people with advanced cancers that have certain KRAS gene changes. Researchers want to find the safest and best dose of BBO 11818 when it is given by itself and when it is combined with other cancer treatments.
The study will also look at both the helpful and harmful effects of the medicine. BBO 11818 may be given alone or together with other cancer medicines, including immunotherapy and chemotherapy drugs. The goal is to learn if this new treatment can help control cancer and improve future treatment options for people with advanced solid tumors.
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
Pending Open to Enrollment