UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

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

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.

Study Overview

• Status: Recruiting
• Conditions: Relapsed/Refractory B-cell Malignancies
• Intervention / Treatment: Drug: UBX-303061

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Project Manager; Phone Number: +82 (2) 6334 2475; Email: ubix_co@ubixtrx.com

Study Locations

• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
      • Not yet recruiting
      • MICS Centrum Medyczne Torun
  • Mazowieckie Voivodeship
    • Warsaw, Mazowieckie Voivodeship, Poland, 02-172
      • Not yet recruiting
      • Pratia, MTZ Clinical Research
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-519
      • Not yet recruiting
      • Pratia, Oncology Katowice
  • Wielkopolskie Voivodeship
    • Grodzisk Wielkopolski, Wielkopolskie Voivodeship, Poland, 62-065
      • Not yet recruiting
      • Aidport
• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • Seoul, Seoul, South Korea, 05505
      • Recruiting
      • Asan Medical Center
    • Seoul, Seoul, South Korea, 06591
      • Recruiting
      • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Seoul, Seoul, South Korea, 07345
      • Recruiting
      • The Catholic University of Korea, Yeouido St. Mary's Hospital
• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
  • Oklahoma
    • Canton, Oklahoma, United States, 44718
      • Recruiting
      • Gabrail Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UBX-303061	Drug: UBX-303061; UBX-303061 oral dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with Protocol Specified Dose-Limiting Toxicities	Phase 1a and 1b	28-days
To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)	Phase 1a and 1b	Up to End of Treatment (up to 9 months)
Number of subjects with dose interruptions, reductions, and doses administered	Phase 1a and qb	Up to End of Treatment (up to 9 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response	Phase 1a and 1b	Up to End of Treatment (up to 9 months)
To assess genetic markers including but not limited to BTK, PLCG2, MYD88	Phase 1a and 1b	Up to End of Treatment (up to 9 months)
To assess Cmin	Phase 1a and 1b	28-days
To assess tmax	Phase 1a and 1b	28-days
To assess AUC	Phase 1a and 1b	28-days
To assess Cmax	Phase 1a and 1b	28-days

Collaborators and Investigators

• Sponsor: Ubix Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: September 8, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence
• Other Study ID Numbers: UBX-303-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No