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JAB-8263 monotherapy in adult participants with advanced solid tumors

JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins.

The objectives of this study are:

To determine the maximum-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced solid tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc) To evaluate preliminary antitumor activity of JAB-8263.

Inclusion Criteria:

Subjects must meet all the following criteria in order to be included in the research study:

Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.
Patients must have at least one measurable lesion as defined by RECIST v1.1.

United States, Colorado
SCRI HeatlthONE  
Denver, Colorado, United States, 80218
Contact: Gerald Falchook, MD         
United States, Florida
Florida Cancer Center, Lake Mary  
Lake City, Florida, United States, 32025
Contact: Shekeab Jauhari, MD         
United States, Tennessee
Tennessee Oncology Nashville  
Nashville, Tennessee, United States, 37203
Contact: James M Pauff, MD PhD       
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587479