Recruiting NCT06590961
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UBX-303061.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory B-cell Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Poland, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug UBX-303061
UBX-303061 oral dosage
Primary outcome measures
- Number of subjects with Protocol Specified Dose-Limiting Toxicities [Time frame: 28-days]
- To establish the maximum tolerated dose and/or recommended Phase 1b dose(s) [Time frame: Up to End of Treatment (up to 9 months)]
- Number of subjects with dose interruptions, reductions, and doses administered [Time frame: Up to End of Treatment (up to 9 months)]
Secondary outcome measures (6)
- 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
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Poland · 4 centers
- MICS Centrum Medyczne Toruń — Torun
- Pratia, MTZ Clinical Research — Warsaw
- Pratia, Oncology Katowice — Katowice
- AidPort — Grodzisk Wielkopolski
South Korea · 4 centers
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
- The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul
- The Catholic University of Korea, Yeouido St. Mary's Hospital — Seoul
United States · 3 centers
- University of Michigan — Ann Arbor
- Gabrail Cancer Center — Canton
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06590961 · UBX-303-101