A Phase Ia/Ib, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
Summary
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.
Arms & interventions
- DrugUBX-303061
UBX-303061 oral dosage
Outcome measures
Primary
Number 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)
Secondary
To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response
Time frame: Up to End of Treatment (up to 9 months)
To assess genetic markers including but not limited to BTK, PLCG2, MYD88
Time frame: Up to End of Treatment (up to 9 months)
To assess Cmin
Time frame: 28-days
To assess tmax
Time frame: 28-days
To assess AUC
Time frame: 28-days
To assess Cmax
Time frame: 28-days
Eligibility criteria
Study locations (3)
University of Michigan
Ann Arbor, Michigan, 48109
Gabrail Cancer Center
Canton, Oklahoma, 44718
MD Anderson Cancer Center
Houston, Texas, 77030