This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
UBX-303061 oral dosage
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGGabrail Cancer Center
Canton, Oklahoma, United States
RECRUITINGNumber of subjects with Protocol Specified Dose-Limiting Toxicities
Phase 1a and 1b
Time frame: 28-days
To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)
Phase 1a and 1b
Time frame: Up to End of Treatment (up to 9 months)
Number of subjects with dose interruptions, reductions, and doses administered
Phase 1a and qb
Time frame: Up to End of Treatment (up to 9 months)
To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response
Phase 1a and 1b
Time frame: Up to End of Treatment (up to 9 months)
To assess genetic markers including but not limited to BTK, PLCG2, MYD88
Phase 1a and 1b
Time frame: Up to End of Treatment (up to 9 months)
To assess Cmin
Phase 1a and 1b
Time frame: 28-days
To assess tmax
Phase 1a and 1b
Time frame: 28-days
To assess AUC
Phase 1a and 1b
Time frame: 28-days
To assess Cmax
Phase 1a and 1b
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MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGMICS Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship, Poland
NOT_YET_RECRUITINGPratia, MTZ Clinical Research
Warsaw, Mazowieckie Voivodeship, Poland
NOT_YET_RECRUITINGPratia, Oncology Katowice
Katowice, Silesian Voivodeship, Poland
NOT_YET_RECRUITINGAidPort
Grodzisk Wielkopolski, Wielkopolskie Voivodeship, Poland
NOT_YET_RECRUITINGAsan Medical Center
Seoul, Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, Seoul, South Korea
RECRUITINGThe Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul, South Korea
RECRUITING...and 1 more locations
Time frame: 28-days