UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
NCT ID: NCT06590961
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
94 participants
INTERVENTIONAL
2025-02-20
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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UBX-303061
UBX-303061
UBX-303061
UBX-303061 oral dosage
Interventions
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UBX-303061
UBX-303061 oral dosage
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ubix Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Michigan
Ann Arbor, Michigan, United States
Gabrail Cancer Center
Canton, Oklahoma, United States
MD Anderson Cancer Center
Houston, Texas, United States
MICS Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Pratia, MTZ Clinical Research
Warsaw, Mazowieckie Voivodeship, Poland
Pratia, Oncology Katowice
Katowice, Silesian Voivodeship, Poland
AidPort
Grodzisk Wielkopolski, Wielkopolskie Voivodeship, Poland
Asan Medical Center
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Other Identifiers
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UBX-303-101
Identifier Type: -
Identifier Source: org_study_id
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