Actively Recruiting
A Phase Ia/Ib Open-label Study Evaluating Safety, Pharmacokinetics, and Pharmacodynamics of UBX-303061 in Patients with Relapsed/Refractory B-Cell Malignancies
Led by Ubix Therapeutics, Inc. · Updated on 2025-11-19
94
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating UBX-303061, an investigational oral drug, in patients with relapsed or refractory B-cell malignancies. This first-in-human Phase 1a/1b open-label study aims to assess the safety and anti-cancer activity of UBX-303061 in individuals who have already received at least two prior therapies or have no available treatment options. The study is sponsored by Ubix Therapeutics, Inc. and focuses on determining the drug's maximum tolerated dose and pharmacokinetics. Participants will receive UBX-303061 in a dose-escalation phase (Phase 1a) followed by a dose-expansion phase (Phase 1b) to further evaluate safety and effectiveness. Treatment duration can last up to 9 months, with monitoring for dose-limiting toxicities, dose interruptions, and reductions. The study also examines genetic markers related to B-cell malignancies and collects pharmacodynamic data during the treatment period. During the trial, participants will undergo regular safety assessments, laboratory tests, and evaluations of tumor response based on the appropriate criteria for their disease type. Researchers will track adverse events and pharmacokinetic parameters such as drug concentration over time. The study will last up to 9 months per participant, with ongoing monitoring to understand UBX-303061's effects and tolerability in this patient population.
CONDITIONS
Brief Title
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of giving signed informed consent
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Diagnosed with relapsed and/or refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM, or MZL) with at least 2 prior therapies or no available treatment options
- Have evaluable or measurable disease based on tumor type criteria
- Adequate organ and bone marrow function
You will not qualify if you...
- Received systemic antineoplastic or experimental therapy within 3 weeks or 5 half-lives before first study dose
- Received tyrosine kinase inhibitor within 5 half-lives before first study dose
- Received unconjugated monoclonal antibody therapies within 6 weeks before first study dose
- Underwent autologous stem cell rescue within 100 days before first study dose
- Underwent allogeneic stem cell transplant within 6 months before first study dose
- Have active graft-versus-host disease or on anti-GVHD treatment
- History of CAR-T therapy within 100 days before study drug start
- Received immunotherapy within 4 weeks before first study dose
- Time from last chemotherapy or experimental therapy to study drug less than 5 times the half-life of prior agents
- Previously exposed to BTK degradation therapy
- Have malignant disease other than that being treated
- Received radiotherapy within 2 weeks before first study dose
- Known hypersensitivity to BTK degraders or ingredients
- Impaired cardiac function or significant cardiac disease
- History of severe bleeding disorders or other autoimmune diseases
- Major surgery within 4 weeks before first study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 months
Participants receive the study drug UBX-303061 orally and are monitored for safety and effectiveness.
Visits occur throughout treatment for dosing and assessments
Trial Site Locations
Total: 11 locations
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
Gabrail Cancer Center
Canton, Oklahoma, United States, 44718
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
MICS Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Not Yet Recruiting
5
Pratia, MTZ Clinical Research
Warsaw, Mazowieckie Voivodeship, Poland, 02-172
Not Yet Recruiting
6
Pratia, Oncology Katowice
Katowice, Silesian Voivodeship, Poland, 40-519
Not Yet Recruiting
7
AidPort
Grodzisk Wielkopolski, Wielkopolskie Voivodeship, Poland, 62-065
Not Yet Recruiting
8
Asan Medical Center
Seoul, Seoul, South Korea, 05505
Actively Recruiting
9
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Actively Recruiting
10
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul, South Korea, 06591
Actively Recruiting
11
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Seoul, South Korea, 07345
Actively Recruiting
Research Team
P
Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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