SAFETY, EFFICACY, AND TOLERABILITY OF BOS172738 IN PATIENTS WITH ADVANCED REARRANGED DURING TRANSFECTION (RET) GENE-ALTERED TUMORS

Boston Pharmaceuticals

RET-altered Non Small Cell Lung Cancer, RET altered Medullary Thyroid Cancer

Interventionnelle

1

114 participants

BOS172738-01@precisionformedicine.com

France: Institut Gustave Roussy, Institut Bergonié (bordeaux), Belgique, Espagne

Number of participants with any treatment-emergent serious adverse event, with any non-serious TEAE, with grade 3, grade 4, or grade 5 TEAEs, with any related TEAE, with any TEAE leading to study drug discontinuation

Maximum tolerated dose

Recommended phase 2 dose

Objective Response Rate, Objective Disease Control Rate, Progression-Free Survival, Duration of Response Time to Response, Duration of Complete Response

•    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

•    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