Clinical Trials in Poland / NCT06590961
Recruiting
Phase 1
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
NCT06590961 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Relapsed/Refractory B-cell Malignancies
Investigational drug(s) / intervention(s)
UBX-303061
UBX-303061: UBX-303061 oral dosage
Study 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
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
Primary outcome measure(s)
- Number of subjects with Protocol Specified Dose-Limiting Toxicities — 28-days
Phase 1a and 1b - To establish the maximum tolerated dose and/or recommended Phase 1b dose(s) — Up to End of Treatment (up to 9 months)
Phase 1a and 1b - Number of subjects with dose interruptions, reductions, and doses administered — Up to End of Treatment (up to 9 months)
Phase 1a and qb
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Gabrail Cancer Center | Canton | Oklahoma | Withdrawn |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| MICS Centrum Medyczne Toruń | Torun | Kuyavian-Pomeranian Voivodeship | Recruiting |
| Pratia, MTZ Clinical Research | Warsaw | Mazowieckie Voivodeship | Not Yet Recruiting |
| Pratia, Oncology Katowice | Katowice | Silesian Voivodeship | Not Yet Recruiting |
| AidPort | Grodzisk Wielkopolski | Wielkopolskie Voivodeship | Recruiting |
| Asan Medical Center | Seoul | Seoul | Recruiting |
| Samsung Medical Center | Seoul | Seoul | Recruiting |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | Seoul | Recruiting |
| The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | Seoul | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06590961 on ClinicalTrials.gov ↗ ← All trials in Poland