Purpose of this Study
The study begins with a screening period that lasts about four weeks. During this time, doctors check your health with a medical history, an exam, blood and urine tests, heart tests, and imaging scans. If you qualify, you will start the treatment part of the study to see how well the chosen dose works. The study drug is called BH 30643. It is a pill taken by mouth on an empty stomach, usually once or twice a day. During the first three weeks, there are several clinic visits. After that, visits happen about every three weeks until Cycle 9, and then about every six weeks. You will also have regular blood tests, heart tests, and scans every six weeks, then every twelve weeks after thirty six weeks.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have non small cell lung cancer that has EGFR or HER2 gene changes. They must be willing and able to come to study visits, have blood tests and scans, and take the study pill the way the doctor instructs. People who can become pregnant, and men with partners who can become pregnant, must follow rules to prevent pregnancy. The study team will make sure each person fully qualifies during screening.
Age Range
18-100
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 the first time the new pill BH 30643 is being tested in people. It has not been approved by the FDA. The study will check if the pill is safe and how the body uses it. Researchers will test different dose levels to learn about side effects, how much of the drug enters the blood, and whether it shows early signs of shrinking or slowing down lung cancer that has certain gene changes called EGFR or HER2.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1/2 Open-Label, Multicenter, First-in- Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH- 30643 in Adult Subjects with Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations (SOLARA)
Principal Investigator
Thomas
Stinchcombe
Protocol Number
PRO00119642
NCT ID
NCT06706076
Phase
I/II
Enrollment Status
Pending Open to Enrollment