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

Trial Title: UBX-303061 in Subjects with Relapsed/Refractory B-Cell Malignancies

NCT ID: NCT06590961

Condition: Relapsed/refractory B-cell Malignancies

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Intervention model description: Phase 1a: Dose escalation study Phase 1b: Dose expansion study

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: UBX-303061
Description: UBX-303061 oral dosage
Arm group label: UBX-303061

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 2024

Completion date: August 2027

Lead sponsor:
Agency: Ubix Therapeutics, Inc.
Agency class: Industry

Source: Ubix Therapeutics, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06590961