Evaluating UBX-303061 for patients with relapsed/refractory B-cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1a/1b multicenter, open-label study aims to assess the safety and anti-cancer efficacy of UBX-303061 in individuals suffering from relapsed or refractory B-cell malignancies. The trial includes a dose-escalation phase for patients who have undergone at least two prior therapies and have no available treatment options. Participants will be monitored for measurable disease and must meet specific organ function criteria to qualify for the study.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• MICS Centrum Medyczne Toruń
  Torun, Kuyavian-Pomeranian Voivodeship, Poland Recruiting
• AidPort
  Grodzisk Wielkopolski, Wielkopolskie Voivodeship, Poland Recruiting
• Asan Medical Center
  Seoul, Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Project Manager
• Email: ubix_co@ubixtrx.com
• Phone: +82 (2) 6334 2475

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.