NCT06590961PHASE1Recruiting
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
Ubix Therapeutics, Inc.
Start Date
2/20/2025
Completion Date
8/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Key Inclusion Criteria
* Capable of giving signed informed consent
* Age ≥18 years
* ECOG performance status ≤2.
* Phase Ia (dose-escalation part only): Subjects with relapsed and/or refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.
* Phase Ib (dose-expansion only): Subjects with relapsed and/or refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL/SLL or DLBCL or MCL or FL, WM, MZL
* All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria
* Adequate organ and bone marrow function
Key Exclusion Criteria
* For subjects with lymphoma:
* Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.
* Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.
* Unconjugated monoclonal antibody therapies \<6 weeks before the first dose of study treatment.
* Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.
* Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.
* Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.
* History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.
* Any immunotherapy within 4 weeks of first dose of study drug.
* The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is \<5 times the t1/2 of the previously administered agent(s).
* Previously exposed to BTK degradation therapy
* Malignant disease, other than that being treated in this study.
* Radiotherapy within 2 weeks of the first dose of study treatment
* Known hypersensitivity to BTK degraders or any of the ingredients.
* Impaired cardiac function or clinically significant cardiac disease
* Subjects with history of severe bleeding disorders and known/suspected other autoimmune disease
* Major surgery within 4 weeks of the first dose of study treatment
Interventions
DRUG
UBX-303061
Conditions
Relapsed/Refractory B-cell Malignancies
Locations
University of Michigan
Ann Arbor, Michigan 48109
United States
Gabrail Cancer Center
Canton, Oklahoma 44718
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
MICS Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship 87-100
Poland
Pratia, MTZ Clinical Research
Warsaw, Mazowieckie Voivodeship 02-172
Poland
Pratia, Oncology Katowice
Katowice, Silesian Voivodeship 40-519
Poland
AidPort
Grodzisk Wielkopolski, Wielkopolskie Voivodeship 62-065
Poland
Asan Medical Center
Seoul, Seoul 05505
South Korea
Samsung Medical Center
Seoul, Seoul 06351
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul 06591
South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Seoul 07345
South Korea