Purpose of this Study
In this study, people will take a medicine called S241656 by mouth. They may take it by itself or with other cancer treatments, and they may take it once or twice a day depending on their study group. The study has two parts. In Part 1, people receive different amounts of the medicine so researchers can find the safest dose. In Part 2, people receive the safest dose that was found in Part 1. Participants will keep taking the medicine until their cancer gets worse or the side effects become too strong or happen too often.
During the study, they will visit the clinic regularly and have many tests, including blood tests, urine tests, and scans. The whole study is expected to last about five years.
Who Can Participate?
Eligibility
People can join this study if they are 18 years or older and have advanced or metastatic cancer with certain gene changes, such as KRAS, HRAS, NRAS, BRAF, or CRAF mutations. They must not be able to have surgery to remove their cancer and must have already tried at least one other treatment.
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
The purpose of this study is to find out if the medicine S241656 can help treat cancers that have certain changes, called mutations, in genes such as KRAS, BRAF, or other RAS genes.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies
Principal Investigator
John
Strickler
Protocol Number
PRO00119545
NCT ID
NCT05786924
Phase
I/II
Enrollment Status
Pending Open to Enrollment