Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors

Inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

• Male or female participants must be ≥ 18 years, at the time of signing the informed consent
• Diagnosis of advanced solid tumor with a documented rearranged during transfection (RET) gene altered malignancy as determined locally by a DNA based assay of tumor tissue and/or blood
• Participants must have no alternative approved therapy.
• For participants in Part B expansion cohort only: documented local diagnosis of either 1) advanced RET gene fusion non-small cell lung cancer (NSCLC); 2) advanced RET gene mutant medullary thyroid cancer (MTC); or 3) other RET gene altered advanced tumors or NSCLC/MTC with prior specific RET gene targeted therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Negative pregnancy test for females of child bearing potential; must be surgically sterile, postmenopausal, or willing and able to be compliant with a contraceptive regimen
• Contraceptive use by men or women should be consistent with local regulations.
• Capable of giving signed informed consent

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• Inability to take oral medications or gastrointestinal (GI) conditions that can interfere with the swallowing or absorption of study medication
• Uncontrolled or severe concurrent medical condition
• History of upper GI bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug
• Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug
• Participants with known infection with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) (testing not required)
• Participants who are hepatitis B surface antigen positive or participants who are hepatitis C antibody positive (Participants who have been successfully treated for hepatitis C virus [HCV] are eligible if an undetectable HCV viral load at least 6 months after completion of treatment can be demonstrated.)
• Any evidence of serious active infections
• Uncontrolled or severe cardiovascular disease
• Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
• Participants with a prior or concurrent malignancy other than the malignancies under study
• Ongoing cancer directed therapy