Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1

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

NCT ID: NCT06590961Sponsor: Ubix Therapeutics, Inc.Last updated: 2025-11-19

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.

Arms & interventions

  • DrugUBX-303061

    UBX-303061 oral dosage

Outcome measures

Primary

  • Number of subjects with Protocol Specified Dose-Limiting Toxicities

    Phase 1a and 1b

    Time frame: 28-days

  • To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)

    Phase 1a and 1b

    Time frame: Up to End of Treatment (up to 9 months)

  • Number of subjects with dose interruptions, reductions, and doses administered

    Phase 1a and qb

    Time frame: Up to End of Treatment (up to 9 months)

Secondary

  • 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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

University of Michigan

Ann Arbor, Michigan, 48109

Recruiting

Gabrail Cancer Center

Canton, Oklahoma, 44718

Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030

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